Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YUCNA
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| ADC Name |
BL-M08D1
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| Synonyms |
BL-M08D1; BL-M19D1
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| Organization |
Systimmune (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
Ed-04
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Payload Info | ||||
| Payload 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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2027 Update
The indication 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 |
2 Trials
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| Unspecific hematological malignancies |
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 |
Eligible patients (18-75 years) have recurrent/refractory lymphoid malignancies, ECOG≤2, adequate organ function, and no standard treatment options. Exclusions include recent anticancer therapy (<4 weeks), uncontrolled cardiac/autoimmune diseases, active infections (HIV/HBV/HCV), ILD, CNS involvement, or pregnancy. Archived tumor tissue within 2 years is 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 | NCT06718634 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Relapsed or Refractory Lymphoid Malignancies | ||||
| Primary Endpoint |
The study evaluates safety in Phase Ia by assessing dose-limiting toxicities (DLTs) per NCI-CTCAE v5.0 within 21 days post-first dose to determine the maximum tolerated dose (MTD). Phase Ib defines the recommended Phase II dose (RP2D) based on integrated safety, efficacy, PK/PD data over ~24 months.
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| Other Endpoint |
Treatment-emergent adverse events (TEAEs) and PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough) are monitored for ~24 months. Immunogenicity (ADA) and efficacy endpoints (ORR, DCR, DOR per RECIST 1.1) are assessed in Phase Ib to evaluate tumor response and disease control.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, Phase Ia; ≥18 years, Phase Ib) have incurable metastatic solid tumors, ECOG 0-1, ≥3-month life expectancy, and measurable lesions. Exclusions include recent anticancer therapy (<4 weeks), uncontrolled cardiovascular disease, active infections (HIV/HBV/HCV), ILD, CNS metastases, organ transplants, or pregnancy. Contraception is required for 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 | NCT06718621 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The Phase Ia study evaluates dose-limiting toxicity (DLT) per NCI-CTCAE v5.0 within 21 days post-dose to determine the maximum tolerated dose (MTD), while Phase Ib establishes the recommended Phase II dose (RP2D) over 24 months based on integrated safety, efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) data for BL-M08D1.
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| Other Endpoint |
Safety assessments include treatment-emergent adverse events (TEAEs), PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough), and immunogenicity (ADA) over 24 months. Efficacy is evaluated via objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) per RECIST 1.1 criteria in Phase Ib.
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References