eligibility_summary
Inclusion: Adults ≥18 with advanced/metastatic epithelial solid tumors lacking options or refractory, measurable, ECOG 0–1, adequate labs, prior SOC as applicable. Combo: ≤2 lines, ≤1 prior PD‑1/PD‑L1. Exclusion: pregnancy/lactation, symptomatic brain mets/recent CNS RT/surgery, O2 need, prior Trop‑2, ILD, recent therapy/surgery, severe mAb/BHV‑1510 allergy, LMD, OATP1B1/1B3 inhibitors. Combo excl: cemiplimab allergy, ≥G3 prior irAEs, prior allo transplant, myocarditis, CVD.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06384807 (Phase 1/2). Interventions: 1) BHV-1510 (aka PBI-410/GQ1010), a Trop-2–directed antibody-drug conjugate (ADC). Mechanism: a monoclonal antibody binds the epithelial tumor antigen Trop-2 (TACSTD2) on solid tumors, is internalized, and delivers a cytotoxic payload to kill Trop-2–expressing cancer cells. 2) Cemiplimab, an anti–PD-1 monoclonal antibody (checkpoint inhibitor). Mechanism: blocks PD-1 on T cells to release PD-1/PD-L1–mediated inhibition and restore antitumor immunity. Targets/pathways: Trop-2 on epithelial tumor cells (ADC-mediated targeted cytotoxicity), PD-1 pathway on T cells and the PD-1/PD-L1 axis in the tumor microenvironment (immune activation). Monotherapy and combination cohorts in advanced solid tumors.