Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0IFWXM
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| ADC Name |
izalontamab brengitecan
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| Synonyms |
izalontamab brengitecan; BL-B01D1; BMS-986507; iza-bren
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| Organization |
Sichuan Biokin Pharmaceutical (Originator);Bristol-Myers Squibb (Top20 MNC)
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| Drug Status |
Apprpved in 2026
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Izalontamab
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Antibody Info | Antigen Name | |||
| Payload Name |
Ed-04
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Gly-Mal-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
brengitecan
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | |||||||||||||
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| Brain cancer |
1 Trials
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| Breast cancer |
2 Trials
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1 Trials
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2 Trials
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| Cervical cancer |
1 Trials
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1 Trials
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| Endometrial cancer |
1 Trials
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1 Trials
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| Fallopian tube cancer |
1 Trials
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1 Trials
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| Head and neck cancer |
1 Trials
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1 Trials
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| Lung cancer |
1 Trials
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2 Trials
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1 Trials
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3 Trials
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| Nasopharyngeal cancer |
1 Trials
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1 Trials
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| Oesophageal cancer |
1 Trials
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1 Trials
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| Ovarian cancer |
1 Trials
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1 Trials
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1 Trials
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| Peritoneal cancer |
1 Trials
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| Prostate cancer |
1 Trials
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| Unspecific solid tumor |
5 Trials
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2 Trials
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3 Trials
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| Urothelial cancer |
1 Trials
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1 Trials
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1 Trials
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1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
61.80
40.50 14.30 45.80 7.70 % |
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| Patients Enrolled |
Patients with locally advanced or metastatic solid tumors.
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| Administration Dosage |
BL-B01D1 was administered intravenously at doses of 2.50, 3.00 mg/kg D1D8 Q3W and 4.50, 5.00, 6.00 mg/kg D1 Q3W.
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| Related Clinical Trial | |||||
| NCT Number | NCT05194982 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic solid tumor. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05785039 | Clinical Status | Phase 2 | ||
| Clinical Description | Phase 2a/2b clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05262491 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor. | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05393427 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with locally advanced or metastatic urological tumors and other solid tumors. | ||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05470348 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B01D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors. | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Efficacy Data | AG7 | . . . | |||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, recurrent SCLC after PD-1/PD-L1 and platinum failure, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (LVEF≥50%, no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06500026 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy | ||||
| Primary Endpoint |
Primary endpoints include OS (time from randomization to death) and PFS (time from randomization to progression/death per BICR assessment), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 24 months.
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, HER2-negative breast cancer refractory to standard therapy, measurable lesions per RECIST 1.1, adequate organ function (hematologic/renal/hepatic), resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue submission is mandatory unless waived by the sponsor.
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| Administration Dosage |
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06042894 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer | ||||
| Primary Endpoint |
The primary endpoints include ORR (percentage of participants achieving CR or PR per RECIST 1.1) and RP2D (dose selected for Phase II based on safety, efficacy, PK/PD data), both assessed over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time to progression/death), DCR (percentage with CR/PR/SD), DOR (response duration until progression/death), and TEAEs (adverse events during treatment), all measured within a 24-month timeframe.
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| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, HR+HER2- breast cancer (unresectable/metastatic) with 1-2 prior chemotherapy lines and progression after endocrine/CDK4/6/taxane therapy, measurable lesions (RECIST 1.1), adequate organ function, resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue within 3 years required unless exempted.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06343948 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy | ||||
| Primary Endpoint |
The primary endpoint is PFS (time from randomization to progression/death per BICR assessment) evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints include OS (time to death), ORR (CR+PR rate in FAS), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA frequency, all monitored for 24 months.
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| Experiment 9 Reporting the Activity Date of This ADC | [9] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, triple-negative breast cancer (unresectable/metastatic) with 1-2 prior chemotherapy lines including taxanes, measurable lesions (RECIST 1.1), stable treated brain metastases if present, adequate organ function, resolved prior toxicity (≤Grade 1), and contraception compliance. Archived/fresh tumor tissue within 3 years required.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06382142 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure | ||||
| Primary Endpoint |
The co-primary endpoints are PFS (time from randomization to progression/death per BICR) and OS (time to death), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints include ORR (CR+PR rate in FAS), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA frequency, all monitored for 24 months.
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| Experiment 10 Reporting the Activity Date of This ADC | [10] | ||||
| Patients Enrolled |
Inclusion criteria: signed consent, age 18-75, ECOG 0-1, treatment-naive triple-negative breast cancer (unresectable/metastatic), measurable lesions (RECIST 1.1), archived/fresh tumor tissue within 2 years, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test for premenopausal women, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06471205 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer | ||||
| Primary Endpoint |
The primary endpoints are ORR (percentage of patients achieving CR or PR in FAS) and RP2D (dose selected for Phase II based on safety, efficacy, PK/PD data from dose escalation), both assessed over 24 months.
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| Other Endpoint |
Key secondary endpoints include PFS (time from randomization to progression/death per BICR), DCR (percentage with CR/PR/SD per RECIST 1.1), DOR (duration from response to progression/death), and TEAEs (adverse events during BL-B01D1 treatment), all evaluated within 24 months.
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| Experiment 11 Reporting the Activity Date of This ADC | [11] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, KPS≥60, recurrent glioblastoma failing standard therapy, resolved prior toxicity (≤Grade 1), adequate organ function (hematologic/renal/hepatic), LVEF≥50%, negative pregnancy test for premenopausal women, and contraception use during treatment plus 6 months post-treatment. No recent blood products or growth factors within 14 days prior to treatment initiation.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06598787 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma | ||||
| Primary Endpoint |
The primary endpoint is ORR (percentage of participants achieving CR or PR per RECIST 1.1 criteria), with pharmacokinetic parameters including Cmax, Tmax, and Ctrough of BL-B01D1 being evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA incidence, all monitored for 24 months.
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| Experiment 12 Reporting the Activity Date of This ADC | [12] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, female patients aged 18-75, ECOG 0-1, recurrent/metastatic gynecological malignancies with measurable lesions (RECIST v1.1), available tumor tissue, adequate organ function (LVEF≥50%, urine protein≤2+), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT05990803 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies | ||||
| Primary Endpoint |
The primary endpoints are ORR (percentage of participants achieving CR/PR per RECIST 1.1) and RP2D (dose determined by safety/efficacy/PK/PD data), both assessed over 24 months.
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| Other Endpoint |
Secondary endpoints include PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), and TEAEs (adverse events during treatment), all evaluated within 24 months.
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| Experiment 13 Reporting the Activity Date of This ADC | [13] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, locally advanced/metastatic GI cancers, measurable lesions (RECIST v1.1), available tumor tissue, adequate organ function (LVEF≥50%, urine protein≤2+), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administered by intravenous infusion every 3 weeks (Q3W).
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| Related Clinical Trial | |||||
| NCT Number | NCT06008054 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors | ||||
| Primary Endpoint |
The primary endpoints are ORR (percentage of participants achieving CR/PR per RECIST 1.1) and RP2D (dose determined based on safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints include PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), and TEAEs (adverse events during treatment), all assessed within 24 months.
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| Experiment 14 Reporting the Activity Date of This ADC | [14] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75 (Phase Ia) or ≥18 (Phase Ib), ECOG 0-1, advanced/metastatic solid tumors (TNBC or others) failing standard therapy, measurable disease (RECIST v1.1), available tumor tissue (preferred), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05262491 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor | ||||
| Primary Endpoint |
Primary endpoints include DLT assessment (NCI-CTCAE v5.0), MTD determination (highest dose with ≤1/6 DLTs), and RP2D selection (based on safety/efficacy/PK/PD data) during the first 21-day cycle.
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| Other Endpoint |
Secondary endpoints comprise TEAEs (treatment-emergent adverse events), PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough), immunogenicity (ADA/Nab), and efficacy measures (ORR, DCR, DOR, PFS) evaluated over 24 months.
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| Experiment 15 Reporting the Activity Date of This ADC | [15] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic esophageal squamous cell carcinoma, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion.
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| Related Clinical Trial | |||||
| NCT Number | NCT06304974 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase Ill Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice as Second Line Treatment in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody in Combination With Platinum-based Chemotherapy | ||||
| Primary Endpoint |
Primary endpoints include PFS (time from randomization to progression/death per BICR assessment) and OS (time from randomization to death), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), PK parameters (Cmax, T1/2), and ADA incidence, all assessed within 24 months.
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| Experiment 16 Reporting the Activity Date of This ADC | [16] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic esophageal squamous cell carcinoma, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT05983432 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include PFS (time from randomization to progression/death per BICR assessment) and OS (time from randomization to death), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), PK parameters (Cmax, T1/2), and ADA incidence, all assessed within 24 months.
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| Experiment 17 Reporting the Activity Date of This ADC | [17] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, recurrent/metastatic gynecological malignancies or other solid tumors failing standard therapy, measurable lesion (RECIST v1.1), available tumor tissue (preferred), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05803018 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies | ||||
| Primary Endpoint |
The primary endpoints include RP2D determination (based on safety/tolerability/efficacy/PK/PD data) in Phase Ib and ORR assessment (CR+PR rate per RECIST 1.1) in Phase II, both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise TEAEs, ORR (Phase Ib), PFS (Phase II), DCR, DOR, PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough), and ADA evaluation across Phases Ib/II, all monitored within 24 months.
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| Experiment 18 Reporting the Activity Date of This ADC | [18] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed recurrent/metastatic HNSCC (non-nasopharyngeal) failing prior therapy, measurable lesion (RECIST 1.1), adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.
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| Related Clinical Trial | |||||
| NCT Number | NCT06006169 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include ORR (percentage achieving CR/PR per RECIST 1.1) and RP2D determination (based on safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), and TEAEs (adverse events during treatment), all assessed within 24 months.
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| Experiment 19 Reporting the Activity Date of This ADC | [19] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed recurrent/metastatic nasopharyngeal carcinoma failing ≥2 prior chemotherapy lines (including platinum), measurable lesion (RECIST v1.1), adequate organ function (hematologic/hepatic/renal), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT06118333 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Trial to Compare BL-B01D1 With Physician's Choice of Chemotherapy (Last Line) in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Previously Treated With PD-1/PD-L1 Monoclonal Antibody and at Least Two Lines of Chemotherapy (at Least One Line of Platinum-based Chemotherapy) | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR rate in FAS) and OS (time from randomization to death), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from randomization to progression/death per BICR), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), PK parameters (Cmax, T1/2), and ADA incidence, all assessed within 24 months.
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| Experiment 20 Reporting the Activity Date of This ADC | [20] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed recurrent/metastatic HNSCC (non-nasopharyngeal) or other solid tumors, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06437522 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR rate in FAS) and RP2D determination (based on safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from randomization to progression/death per BICR), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), and TEAEs (treatment-emergent adverse events), all assessed within 24 months.
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| Experiment 21 Reporting the Activity Date of This ADC | [21] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed locally advanced/metastatic solid tumors (e.g., NSCLC, nasopharyngeal carcinoma), measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05956587 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR rate per RECIST 1.1) and RP2D determination (based on safety/tolerability/efficacy/PK/PD data of SI-B003), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), and TEAEs (treatment-emergent adverse events), all assessed within 24 months.
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| Experiment 22 Reporting the Activity Date of This ADC | [22] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed locally advanced/metastatic NSCLC or nasopharyngeal carcinoma, measurable lesion (RECIST v1.1), available tumor tissue (6-10 slides), adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06475300 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR rate in FAS) and RP2D determination (based on BL-B01D1 safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from randomization to progression/death per BICR), DCR (CR+PR+SD rate per RECIST 1.1), DOR (response duration to progression/death), and TEAEs (treatment-emergent adverse events), all assessed within 24 months.
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| Experiment 23 Reporting the Activity Date of This ADC | [23] | ||||
| Patients Enrolled |
Key eligibility criteria: measurable disease (RECIST), ECOG 0-1, life expectancy ≥3 months. Exclusions: mixed SCLC/NSCLC histology, untreated CNS metastases, recurrent infections, or severe cardiac disease. Other protocol-specific criteria apply.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06618287 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors | ||||
| Primary Endpoint |
Safety endpoints include incidence of AEs, SAEs, DLTs (within 3 weeks), treatment discontinuations, and deaths, all monitored for up to 3 years.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, AUC (0-T), AUC (TAU)) and efficacy measures (ORR, DOR) will be evaluated over 3 years.
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| Experiment 24 Reporting the Activity Date of This ADC | [24] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG ≤1, histologically confirmed locally advanced/metastatic NSCLC, measurable lesion (RECIST v1.1), available tumor tissue, adequate organ function (LVEF ≥50%, INR ≤1.5, APTT ≤1.5×ULN, urinary protein ≤2+/1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use.
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05880706 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer | ||||
| Primary Endpoint |
Primary endpoints include RP2D determination based on BL-B01D1 safety/tolerability/efficacy/PK/PD data and ORR (CR+PR per RECIST 1.1), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), and TEAEs (adverse events during treatment), all assessed within 24 months.
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| Experiment 25 Reporting the Activity Date of This ADC | [25] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, histologically confirmed extensive-stage SCLC (Cohort_A: ≥3L treatment failure/intolerance; Cohort_B: 1L failure or treatment-naive), measurable lesion (RECIST v1.1), available tumor tissue (10 slides within 3 years), adequate organ function, negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05924841 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR per RECIST 1.1) and RP2D determination (based on SI-B003 safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), and TEAEs (treatment-emergent adverse events), all assessed within 24 months.
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| Experiment 26 Reporting the Activity Date of This ADC | [26] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed EGFR-mutated non-squamous NSCLC with progression on 3rd-gen EGFR-TKI, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function, negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06382116 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure | ||||
| Primary Endpoint |
Primary endpoints include PFS (time from randomization to progression/death per BICR assessment) and OS (time from randomization to death), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 24 months.
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| Experiment 27 Reporting the Activity Date of This ADC | [27] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, histologically confirmed EGFR wild-type NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (LVEF≥50%, urine protein≤2+/<1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
Click to Show/Hide
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06382129 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy | ||||
| Primary Endpoint |
Primary endpoints include OS (time from randomization to death) and PFS (time from randomization to progression/death per BICR assessment), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 24 months.
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| Experiment 28 Reporting the Activity Date of This ADC | [28] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG 0-1, newly diagnosed extensive-stage SCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years), adequate organ function (no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
Click to Show/Hide
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06437509 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer | ||||
| Primary Endpoint |
Primary endpoints include ORR (CR+PR rate in FAS) and RP2D determination (based on BL-B01D1 safety/tolerability/efficacy/PK/PD data), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from randomization to progression/death per BICR assessment), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), and TEAEs (treatment-emergent adverse events), all assessed within 24 months.
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| Experiment 29 Reporting the Activity Date of This ADC | [29] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG ≤1, histologically confirmed EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 2 years), adequate organ function (LVEF≥50%, INR≤1.5, APTT≤1.5×ULN, urine protein≤2+/≤1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use (7 days pre-dose to 6 months post-dose).
Click to Show/Hide
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06498986 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer | ||||
| Primary Endpoint |
Primary endpoints include RP2D determination (based on BL-B01D1 safety/tolerability/efficacy/PK/PD data) and ORR (CR+PR per RECIST 1.1 criteria), both evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints comprise PFS (time from first dose to progression/death), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), PK parameters (Cmax/Tmax/Ctrough), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 24 months.
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| Experiment 30 Reporting the Activity Date of This ADC | [30] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age ≥18, ECOG 0-1, unresectable/radically irradiated EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (post-diagnosis), adequate organ function (LVEF≥50%, urine protein≤2+/<1000mg/24h, no transfusion/growth factors within 14 days), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
Click to Show/Hide
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| Administration Dosage |
BL-B01D1: administration by intravenous infusion for a cycle of 3 weeks. Osimertinib: oral administration, 80mg daily for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06838273 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | ||||
| Primary Endpoint |
Primary endpoints include PFS (time from randomization to progression/death per BICR assessment) and OS (time from randomization to death), both evaluated over 36 months.
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| Other Endpoint |
Secondary endpoints comprise ORR (CR+PR rate in FAS), DCR (CR+PR+SD per RECIST 1.1), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 36 months.
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| Experiment 31 Reporting the Activity Date of This ADC | [31] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent, age 18-75, ECOG ≤2, histologically confirmed unresectable/metastatic chordoma, measurable disease, adequate organ function (LVEF≥50%, INR≤1.5, APTT≤1.5ULN, urine protein≤2+/<1000mg/24h), resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
Click to Show/Hide
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06787664 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Locally Advanced or Metastatic Chordoma | ||||
| Primary Endpoint |
Primary endpoint is ORR (percentage of participants achieving CR or PR per RECIST 1.1 criteria), evaluated over 24 months.
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| Other Endpoint |
Secondary endpoints include PFS (time from first dose to progression/death), DCR (CR+PR+SD rate), DOR (response duration to progression/death), TEAEs (treatment-emergent adverse events), PK parameters (Cmax, Tmax, Ctrough), and ADA (anti-BL-B01D1 antibody frequency), all assessed within 24 months.
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| Experiment 32 Reporting the Activity Date of This ADC | [32] | ||||
| Patients Enrolled |
Inclusion criteria: signed consent, age 18-75 (Ia)/≥18 (Ib), ECOG 0-1, advanced/metastatic solid tumors (including breast cancer) refractory to standard therapy, measurable lesion (RECIST v1.1), available tumor tissue (within 3 years, waiver possible), adequate organ function, resolved prior toxicity (≤Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.
Click to Show/Hide
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| Administration Dosage |
Administration by intravenous infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT05470348 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors | ||||
| Primary Endpoint |
Phase Ia primary endpoints include DLT assessment (NCI-CTCAE v5.0 during first cycle) and MTD determination (highest dose not exceeding target DLT rate). Phase Ib focuses on establishing RP2D (dose for phase II based on safety/tolerability/efficacy/PK/PD data), both evaluated within 21 days post-first dose.
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| Other Endpoint |
Key secondary endpoints comprise TEAEs (treatment-emergent adverse events), PK parameters (Cmax, Tmax, T1/2, AUC0-t, Ctrough, CL), immunogenicity (ADA/Nab), and efficacy measures (ORR per RECIST 1.1, DCR, DOR, PFS), with safety/PK assessed within 21 days and efficacy/immunogenicity over 24 months.
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| Experiment 33 Reporting the Activity Date of This ADC | [33] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age 18-75; ECOG 0-1; treatment-naïve unresectable metastatic urothelial carcinoma; available tumor tissue for PD-L1 testing; ≥1 measurable lesion; adequate organ function; resolved prior toxicity (≤Grade 1); negative pregnancy test; contraception use during/6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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||||
| Related Clinical Trial | |||||
| NCT Number | NCT06405425 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma | ||||
| Primary Endpoint |
Primary endpoint is ORR (CR+PR rate per RECIST 1.1) assessed in FAS population over 24 months. Secondary endpoints include BIRC-assessed PFS (time to progression/death) and DCR (CR+PR+SD rate).
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| Other Endpoint |
Additional secondary endpoints comprise DOR (response duration), TEAEs (type/frequency/severity), PK parameters (Cmax, Tmax, Ctrough), and ADA incidence, all evaluated over 24 months.
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| Experiment 34 Reporting the Activity Date of This ADC | [34] | ||||
| Patients Enrolled |
Key inclusion criteria: signed informed consent; age 18-75; ECOG 0-1; platinum and PD-1/PD-L1 inhibitor-refractory metastatic urothelial carcinoma; ≥1 measurable lesion (RECIST v1.1); adequate organ function; resolved prior toxicity (≤Grade 1); negative pregnancy test; contraception use during/6 months post-treatment.
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| Administration Dosage |
Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06857175 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody and Platinum-based Chemotherapy | ||||
| Primary Endpoint |
The primary endpoints include PFS assessed by BIRC (time from randomization to disease progression or death) and OS (time from randomization to death), both evaluated over a 24-month period in patients with advanced urothelial carcinoma.
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| Other Endpoint |
Secondary endpoints consist of ORR (CR+PR rate per RECIST 1.1), DCR (CR+PR+SD rate), DOR (duration from response to progression/death), TEAEs (type/frequency/severity), and ADA incidence, all measured within 24 months
|
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References