eligibility_summary
Eligibility: Adults 18–75 with recurrent/metastatic non-nasopharyngeal HNSCC, ECOG 0–1, ≥3‑mo survival, measurable disease, tumor tissue (or waiver), adequate organ/cardiac function, cohort-based prior therapy (A/B & C‑Stage I: failed/intolerant ≥1L, C‑Stage II: no prior systemic), prior toxicities ≤G1, contraception. Exclude: prior topo‑I ADC, recent therapy/immunomodulators/steroids, non‑SCC, major CV/autoimmune/ILD, uncontrolled DM/HTN, active CNS mets/infection, other malignancy, transplant, HBV/HCV/HIV, allergy, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06006169 (Phase II) in recurrent/metastatic HNSCC and other solid tumors. Interventions and MOA: - BL-B01D1 (izalontamab brengitecan, BMS-986507): an antibody–drug conjugate (ADC), bispecific for EGFR and HER3 (ErbB family). Upon binding to tumor cells, it is internalized and releases a topoisomerase I inhibitor (“brengitecan”) to induce DNA damage and cell death. - SI-B003: a monoclonal antibody immune checkpoint inhibitor that blocks PD-1 to restore T‑cell antitumor activity. Targeted cells/pathways: - Tumor cells expressing EGFR/HER3, inhibition of EGFR/ERBB signaling plus delivery of a topo I cytotoxic payload affecting DNA replication/repair. - T lymphocytes via PD-1/PD-L1 axis, enhancing immune-mediated tumor killing. Arms: BL-B01D1 monotherapy, SI-B003 monotherapy, and their combination.