eligibility_summary
Eligible: Women 18–75 with recurrent/metastatic gynecologic cancer after standard therapy failure, ECOG 0–1, survival ≥3 mo, measurable disease, adequate organs (LVEF ≥50%, proteinuria ≤2+), not pregnant/lactating, contraception, provide tumor tissue. Exclude: prior topo‑I ADC, recent anti‑cancer or immunomod therapy, severe irAEs, serious CV disease, active autoimmune/ILD/infection, CNS mets, HTN/DM, VTE, effusions, mAb allergy, transplant, other malignancy, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Interventions and mechanisms: BL-B01D1 (iza-bren, izalontamab brengitecan, BMS-986507) is a bispecific antibody–drug conjugate (ADC) that binds EGFR and HER3 on tumor cells and delivers a topoisomerase I inhibitor payload (brengitecan) to induce DNA damage and cell death. SI-B003 is an immune checkpoint inhibitor monoclonal antibody administered Q3W, it blocks the PD-1/PD-L1 pathway to restore antitumor T‑cell activity. The study tests BL-B01D1 alone, SI-B003 alone, and the combination. - Cells/pathways targeted: Tumor cells overexpressing EGFR and/or HER3, DNA replication/repair via topoisomerase I inhibition, adaptive immunity via PD-1/PD-L1 checkpoint on T cells.