Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0BWWWF
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| ADC Name |
BL-M05D1
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| Synonyms |
BL-M15D1; BL-M05D1
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| Organization |
Systimmune (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
5103F3
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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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 |
Undisclosed
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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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| Oesophageal cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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1 Trials
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| Gastric cancer |
1 Trials
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1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract 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 |
Eligible patients (18-75 years, ECOG 0-1) had advanced solid tumors refractory to standard therapy, measurable lesions, and adequate organ function. Exclusions included recent anticancer therapy, uncontrolled comorbidities, active infections, CNS metastases, or prior BL-M05D1 hypersensitivity. Contraception was mandatory.
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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 | NCT06349811 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
Phase Ia assessed DLTs per NCI-CTCAE v5.0 within 21 days post-first dose to determine MTD (≤1/6 patients with DLTs), while Phase Ib established RP2D over 24 months based on safety, efficacy, PK, and PD data for BL-M05D1.
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| Other Endpoint |
Safety evaluations included TEAEs and PK parameters (Cmax, Tmax, T1/2, AUC0-t, CL, Ctrough, ADA) over 24 months. Efficacy endpoints (ORR, DCR, DOR per RECIST 1.1) were analyzed in Phase Ib, measuring tumor response and disease progression.
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