Antibody Information

General Information of This Antibody (ID: ANTI0ECNQI)
Antibody Name
izalontamab
Antigen Name
EGFR; HER3
  Antigen Info 
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
QVQLKQSGPGLVQPSQSLSITCTVSGFSLTNYGVHWVRQSPGKGLEWLGVIWSGGNTDYN
TPFTSRLSINKDNSKSQVFFKMNSLQSNDTAIYYCARALTYYDYEFAYWGQGTLVTVSSA
STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG
LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP
SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS
TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDEL
TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQ
QGNVFSCSVMHEALHNHYTQKSLSLSPGGGGGSGGGGSQVQLQESGGGLVKPGGSLRLSC
AASGFTFSSYWMSWVRQAPGKGLEWVANINRDGSASYYVDSVKGRFTISRDDAKNSLYLQ
MNSLRAEDTAVYYCARDRGVGYFDLWGRGTLVTVSSGGGGSGGGGSGGGGSQSALTQPAS
VSGSPGQSITISCTGTSSDVGGYNFVSWYQQHPGKAPKLMIYDVSDRPSGVSDRFSGSKS
GNTASLIISGLQADDEADYYCSSYGSSSTHVIFGGGTKVTVL
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Heavy Chain Varible Domain
QVQLKQSGPGLVQPSQSLSITCTVSGFSLTNYGVHWVRQSPGKGLEWLGVIWSGGNTDYN
TPFTSRLSINKDNSKSQVFFKMNSLQSNDTAIYYCARALTYYDYEFAYWGQGTLVTVSSA
STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG
LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGP
SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS
TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDEL
TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQ
QGNVFSCSVMHEALHNHYTQKSLSLSPGGGGGSGGGGSQVQLQESGGGLVKPGGSLRLSC
AASGFTFSSYWMSWVRQAPGKGLEWVANINRDGSASYYVDSVKGRFTISRDDAKNSLYLQ
MNSLRAEDTAVYYCARDRGVGYFDLWGRGTLVTVSSGGGGSGGGGSGGGGSQSALTQPAS
VSGSPGQSITISCTGTSSDVGGYNFVSWYQQHPGKAPKLMIYDVSDRPSGVSDRFSGSKS
GNTASLIISGLQADDEADYYCSSYGSSSTHVIFGGGTKVTVL
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Light Chain Sequence
DILLTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQRTNGSPRLLIKYASESISGIPS
RFSGSGSGTDFTLSINSVESEDIADYYCQQNNNWPTTFGAGTKLELKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
DILLTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQRTNGSPRLLIKYASESISGIPS
RFSGSGSGTDFTLSINSVESEDIADYYCQQNNNWPTTFGAGTKLELKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
izalontamab brengitecan [Apprpved in 2026]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 34 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
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.
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.
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.
Experiment 2 Reporting the Activity Date of This ADC [2]
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.
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.
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.
Experiment 3 Reporting the Activity Date of This ADC [3]
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.
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.
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.
Experiment 4 Reporting the Activity Date of This ADC [4]
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.
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.
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.
Experiment 5 Reporting the Activity Date of This ADC [5]
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.
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.
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.
Experiment 6 Reporting the Activity Date of This ADC [6]
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.
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.
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.
Experiment 7 Reporting the Activity Date of This ADC [7]
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.
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.
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.
Experiment 8 Reporting the Activity Date of This ADC [8]
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).
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.
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.
Experiment 9 Reporting the Activity Date of This ADC [9]
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.
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.
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.
Experiment 10 Reporting the Activity Date of This ADC [10]
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.
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.
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.
Experiment 11 Reporting the Activity Date of This ADC [11]
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
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.
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.
Experiment 12 Reporting the Activity Date of This ADC [12]
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
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.
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.
Experiment 13 Reporting the Activity Date of This ADC [13]
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.
Administration Dosage
BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.
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.
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.
Experiment 14 Reporting the Activity Date of This ADC [14]
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
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.
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.
Experiment 15 Reporting the Activity Date of This ADC [15]
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.
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.
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.
Experiment 16 Reporting the Activity Date of This ADC [16]
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
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.
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.
Experiment 17 Reporting the Activity Date of This ADC [17]
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.
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.
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.
Experiment 18 Reporting the Activity Date of This ADC [18]
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.
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.
Other Endpoint
Pharmacokinetic parameters (Cmax, Tmax, AUC (0-T), AUC (TAU)) and efficacy measures (ORR, DOR) will be evaluated over 3 years.
Experiment 19 Reporting the Activity Date of This ADC [19]
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
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.
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.
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 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
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.
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.
Experiment 21 Reporting the Activity Date of This ADC [21]
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.
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
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.
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.
Experiment 22 Reporting the Activity Date of This ADC [22]
Patients Enrolled
Key inclusion criteria: signed consent, age &ge;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&ge;50%, urine protein&le;2+/<1000mg/24h), resolved prior toxicity (&le;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.
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.
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.
Experiment 23 Reporting the Activity Date of This ADC [23]
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 (&le;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.
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.
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.
Experiment 24 Reporting the Activity Date of This ADC [24]
Patients Enrolled
Key inclusion criteria: signed consent, age &ge;18, ECOG &le;1, histologically confirmed EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (within 2 years), adequate organ function (LVEF&ge;50%, INR&le;1.5, APTT&le;1.5&times;ULN, urine protein&le;2+/&le;1000mg/24h), resolved prior toxicity (&le;Grade 1), negative pregnancy test, and contraception use (7 days pre-dose to 6 months post-dose).

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Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
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.
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.
Experiment 25 Reporting the Activity Date of This ADC [25]
Patients Enrolled
Key inclusion criteria: signed consent, age &ge;18, ECOG 0-1, unresectable/radically irradiated EGFR-mutant NSCLC, measurable lesion (RECIST v1.1), available tumor tissue (post-diagnosis), adequate organ function (LVEF&ge;50%, urine protein&le;2+/<1000mg/24h, no transfusion/growth factors within 14 days), resolved prior toxicity (&le;Grade 1), negative pregnancy test, and contraception use during treatment plus 6 months post-treatment.

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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.
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.
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.
Experiment 26 Reporting the Activity Date of This ADC [26]
Patients Enrolled
Key inclusion criteria: signed consent, age 18-75, ECOG &le;2, histologically confirmed unresectable/metastatic chordoma, measurable disease, adequate organ function (LVEF&ge;50%, INR&le;1.5, APTT&le;1.5ULN, urine protein&le;2+/<1000mg/24h), resolved prior toxicity (&le;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.
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.
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.
Experiment 27 Reporting the Activity Date of This ADC [27]
Patients Enrolled
Inclusion criteria: signed consent, age 18-75 (Ia)/&ge;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 (&le;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
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.
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.
Experiment 28 Reporting the Activity Date of This ADC [28]
Patients Enrolled
Key inclusion criteria: signed consent; age 18-75; ECOG 0-1; treatment-na&iuml;ve unresectable metastatic urothelial carcinoma; available tumor tissue for PD-L1 testing; &ge;1 measurable lesion; adequate organ function; resolved prior toxicity (&le;Grade 1); negative pregnancy test; contraception use during/6 months post-treatment.
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
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).
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.
Experiment 29 Reporting the Activity Date of This ADC [29]
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; &ge;1 measurable lesion (RECIST v1.1); adequate organ function; resolved prior toxicity (&le;Grade 1); negative pregnancy test; contraception use during/6 months post-treatment.
Administration Dosage
Administration by intravenous infusion for a cycle of 3 weeks.
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.
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
Experiment 30 Reporting the Activity Date of This ADC [30]
Efficacy Data Objective Response Rate (ORR)
61.80
40.50
14.30
45.80
7.70 %
Patients Enrolled
Patients with locally advanced or metastatic solid tumors.
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.
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 31 Reporting the Activity Date of This ADC [31]
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 32 Reporting the Activity Date of This ADC [32]
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 33 Reporting the Activity Date of This ADC [33]
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 34 Reporting the Activity Date of This ADC [34]
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.
References
Ref 1 A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer
Ref 2 A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
Ref 3 A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer
Ref 4 A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
Ref 5 A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
Ref 6 A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Ref 7 A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Ref 8 A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors
Ref 9 A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Ref 10 A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Ref 11 Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Ref 12 A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
Ref 13 A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Ref 14 A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Ref 15 A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Ref 16 A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
Ref 17 A Study 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
Ref 18 A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
Ref 19 A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Ref 20 A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer
Ref 21 A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Ref 22 A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer
Ref 23 A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer
Ref 24 A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Ref 25 A 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
Ref 26 A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma
Ref 27 A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Ref 28 A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Ref 29 A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma
Ref 30 BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic solid tumor: Results from a first-in-human phase 1 study. J Clin Oncol. 2023 41:16_suppl, 3001-3001.
Ref 31 Phase IIa/IIb 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, NCT05785039
Ref 32 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, NCT05262491
Ref 33 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 Urological Tumors and Other Solid Tumors, NCT05393427
Ref 34 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, NCT05470348