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BL-B01D1 Alone or in Combination Therapies for Advanced Hepatocellular Carcinoma
NCT06986785Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2025
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- Biokin Pharmaceutical
- Modality
- Bispecific Antibodies, Antibody-Drug Conjugates (ADCs)
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label trial of izalontamab brengitecan in hepatocellular carcinoma (HCC), sponsored by Biokin Pharmaceutical. Primary endpoints: Objective Response Rate at 24 months and Recommended Phase II Dose at 24 months. Started Jun 2025; status: recruiting.
02
Design
1 arm- Study design
- Open-label
Study treatment
BL-B01D1, BL-B01D1 + lenvatinib, BL-B01D1 + finotonlimab, and BL-B01D1 + finotonlimab + bevacizumab
03
Who it enrols
Adults aged 18-75 with advanced hepatocellular carcinoma, ECOG 0-1, adequate organ function, and no prior topoisomerase I inhibitor ADC therapy.
04
Endpoints
Primary
Objective Response Rate
Recommended Phase II Dose
Secondary
Progression-free survival
Disease Control Rate
Duration of Response
Treatment Emergent Adverse Event
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