Antibody Information
General Information of This Antibody (ID: ANTI0KPGYS)
| Antibody Name | Anti-GPC3 antibody |
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| Antigen Name | GPC3 |
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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
BMS-986183 [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key inclusion criteria require advanced unresectable hepatocellular carcinoma (histologically confirmed) with Child-Pugh class A, ECOG 0-1, and contraception use. Exclusions cover prior liver transplant, uncontrolled portal hypertension, CNS metastases, active HBV/HCV/HDV/HIV co-infections, recent cardiovascular events, additional malignancies within 2 years, >2 prior systemic therapies (Part 2 restrictions), concurrent anticoagulation, recent radiotherapy, major allergies, and protocol-specified contraindications. Full eligibility details are available via BMSStudyConnect.com.
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| Related Clinical Trial | |||||
| NCT Number | NCT02828124 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2 Study of BMS-986183 in Subjects With Advanced Hepatocellular Carcinoma
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| Primary Endpoint |
The study evaluates the safety profile of the treatment by monitoring the incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and laboratory toxicity grade shifts over a 24-month period.
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| Other Endpoint |
Efficacy assessments include Best Overall Response (BOR, requiring confirmation scan), Overall Response Rate (ORR), Duration of Response (DoR), Progression-Free Survival (PFS), and PFS rates at predefined intervals (12, 24, 36 weeks). Pharmacokinetic analysis focuses on Cmax, Tmax, AUC (0-T and TAU), Ctrough, CLT, Vss, Vz, accumulation indices (AI_Cmax, AI_Ctau, AI_AUC (TAU)), Css,avg, and T-HALF for BMS-986183 components (total antibody, active ADC, tubulysin) as monotherapy and with nivolumab. Additional endpoints include QTcF changes from baseline and anti-drug antibody (ADA) incidence.
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