Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0JEKTY
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| ADC Name |
BMS-986183
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| Organization |
Bristol-Myers Squibb (Top20 MNC)
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| Drug Status |
Phase 1/2 (discontinued)
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| Drug-to-Antibody Ratio |
3 to 3.5
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| Antibody Name |
Anti-GPC3 antibody
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Antibody Info | ||||
| Antigen Name |
Glypican-3 (GPC3)
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Antigen Info | ||||
| Payload Name |
Tubulysin
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Val-Cit dipeptide linker
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Liver cancer |
1 Trials
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General Information of The Activity Data Related to This ADC
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 |
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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| Administration Dosage |
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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 | ||||
| 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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