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BL-B01D1 vs Chemotherapy in HR+HER2- Breast Cancer
NCT06343948Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2024
- Primary completion
- Aug 2026
- Countries
- 1
- Sponsor
- Biokin Pharmaceutical
- Modality
- Bispecific Antibodies, Antibody-Drug Conjugates (ADCs)
- Conditions
- Hormone-Receptor-Positive Breast Cancer
01
Overview
Phase 3, randomised, open-label trial of izalontamab brengitecan in Hormone-Receptor-Positive Breast Cancer (2 arms), sponsored by Biokin Pharmaceutical. Primary endpoint: Progression-free survival at 24 months. Started Apr 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
BL-B01D1
Intravenous infusion of BL-B01D1 for a cycle of 3 weeks.
Physician's Choice Chemotherapy
Eribulin, Vinorelbine, Gemcitabine, or Capecitabine administered in 3-week cycles.
03
Who it enrols
Adults with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer who have received 1-2 prior lines of chemotherapy, endocrine therapy, CDK4/6 inhibitors, and taxanes, with ECOG 0-1 and adequate organ function. Excludes patients with prior topoisomerase I inhibitor ADCs, active CNS metastases, or severe cardiovascular disease.
04
Endpoints
Primary
Progression-free survival
Secondary
Overall survival
Objective Response Rate
Disease Control Rate
Duration of Response
Treatment Emergent Adverse Event
Anti-drug antibody
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