eligibility_summary
Inclusion: Adults 18–75, ECOG 0–1, life expectancy ≥3 months, recurrent/metastatic HNSCC (non‑NPC) or other solid tumors confirmed, tumor tissue from ≤3 years for PD‑L1, ≥1 measurable lesion (RECIST v1.1), adequate organs, no transfusion/growth factors in last 14 days, prior toxicities ≤G1, contraception/pregnancy test as needed. Exclusion: prior TOP1‑ADC, recent anti‑tumor therapy/RT, prior systemic therapy, severe irAE, recent immunomodulators/steroids, major CV disease/autoimmune/ILD, uncontrolled DM/HTN, recent thrombosis, active CNS mets, symptomatic effusions, serious/active infections (HIV/TB/HBV/HCV), prior transplant, allergy to study drug, recent other trial, substance abuse/psychiatric illness, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: BL-B01D1 (izalontamab brengitecan, BMS-986507), a bispecific antibody–drug conjugate (ADC) that binds EGFR and HER3 on tumor cells and, after internalization, releases a topoisomerase I inhibitor payload (“-tecan,” brengitecan) to induce DNA damage and tumor cell death. PD‑1 monoclonal antibody (immune checkpoint inhibitor, MeSH indicates spartalizumab) blocks PD‑1 on T cells to restore antitumor activity. Targets/pathways: EGFR and HER3 receptor tyrosine kinases on cancer cells to drive selective ADC uptake, DNA replication/repair via topo I inhibition leading to apoptosis, and the PD‑1/PD‑L1 immune checkpoint on exhausted T cells in the tumor microenvironment. Population: recurrent/metastatic HNSCC (non‑NPC) and other solid tumors, IV q3w combination, single‑arm phase II.