Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0TIYUW |
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| Antibody Name | 5103F3 |
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| Antigen Name | CLDN18.2 |
Antigen Info | ||||
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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
BL-M05D1 [Phase 3]
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
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| 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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