Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0TWRCD)
| ADC Name |
BL-M17D1
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| Synonyms |
BL-M17D1
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| Organization |
Sichuan Biokin Pharmaceutical (Originator)
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| Drug Status |
Phase 1
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| Antibody Name |
Anti-HER2 antibody
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2)
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Antigen Info | ||||
| Payload Name |
WA-00
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Undisclosed
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| Conjugate Type |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||||
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| Unspecific solid tumor |
3 Trials
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| Oesophageal cancer |
2 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Gastric cancer |
3 Trials
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| Colorectal cancer |
2 Trials
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| Pancreatic cancer |
2 Trials
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| Lung cancer |
1 Trials
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| Breast cancer |
2 Trials
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| Ovarian cancer |
1 Trials
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| Urothelial cancer |
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] | ||||
| Patients Enrolled |
Inclusion: Signed consent, age 18-75 (Ia) or ≥18 (Ib), HER2+/- solid tumors, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function. Exclusion: Recent antitumor therapy, uncontrolled comorbidities (cardiac, autoimmune, infections), CNS metastases, allergies to BL-M17D1, pregnancy, or investigator-assessed ineligibility.
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| Administration Dosage |
Participants receive BL-M17D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
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| Related Clinical Trial | |||||
| NCT Number | NCT06500052 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors | ||||
| Primary Endpoint |
Phase Ia assesses DLTs (NCI-CTCAE v5.0) and MTD (highest dose with ≤1/6 DLTs) within 21 days post-first dose. Phase Ib determines RP2D (within ~24 months) based on integrated safety, efficacy, PK, and PD data.
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| Other Endpoint |
TEAEs (type/frequency/severity) and PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough) are monitored for ~24 months. Immunogenicity (ADA) and efficacy (ORR, DCR per RECIST 1.1; DOR) are evaluated in Phase Ib.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Inclusion: Signed consent, age ≥18, HER2+/- solid tumors, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function. Exclusion: Recent antitumor therapy, uncontrolled comorbidities (cardiac, autoimmune, infections), CNS metastases, allergies to BL-M17D1, pregnancy, or investigator-assessed ineligibility.
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| Administration Dosage |
The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 via by intravenous infusion every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06714617 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M17D1 in Subjects with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study evaluates dose-limiting toxicities (DLTs) including hematologic (Grade 4 neutropenia >7 days, febrile neutropenia ≥Grade 3) and nonhematologic toxicities (Grade ≥3 events, Hy's law cases) over 1 year. MTD, MAD, and RDEs of BL-M17D1 will be determined, alongside monitoring of SAEs and TEAEs.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Inclusion: Signed consent, age 18-75 (Ia) or ≥18 (Ib), HER2+/- solid tumors, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function. Exclusion: Recent antitumor therapy, uncontrolled comorbidities (cardiac, autoimmune, infections), CNS metastases, allergies to BL-M17D1, pregnancy, or investigator-assessed ineligibility.
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| Administration Dosage |
Participants receive BL-M17D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
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| Related Clinical Trial | |||||
| NCT Number | NCT06503783 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors | ||||
| Primary Endpoint |
Phase Ia evaluates DLTs (NCI-CTCAE v5.0) and MTD (highest dose with ≤1/6 DLTs) within 21 days post-first dose. Phase Ib determines RP2D (up to 24 months) based on integrated safety, efficacy, PK, and PD data.
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| Other Endpoint |
TEAEs (type/frequency/severity) and PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough) are monitored for 24 months. Immunogenicity (ADA) and efficacy (ORR/DCR per RECIST 1.1, DOR) are assessed in Phase Ib.
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References