Phase 12 First in Human Study of BHV-1510 Alone and With Cemiplimab for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BHV-1510, a Trop-2 directed antibody-drug conjugate, alone and combined with cemiplimab in adults with previously treated, advanced solid tumors that are incurable or have no standard therapies left. This Phase 12 open-label study aims to assess safety, tolerability, and preliminary effectiveness in this population, including determination of recommended doses and maximum tolerated doses of BHV-1510. The study includes two parts Phase 1 dose escalation to test BHV-1510 alone and with cemiplimab, and Phase 2 dose expansion to further assess response rates and safety. BHV-1510 is given intravenously on various schedules, including every 2 or 3 weeks, sometimes with cemiplimab infusions every 3 weeks. The combination dosing regimens vary, with cemiplimab given at 350 mg on Day 1 or Day 1 and Day 8 every 3 weeks. Participants will undergo regular safety assessments, including monitoring adverse events and laboratory tests. Researchers will measure BHV-1510 levels in blood and evaluate tumor response using imaging and standard criteria. The study may last up to about 47 months, with ongoing follow-up to assess duration of response, progression-free survival, overall survival, and other clinical outcomes. Safety and tolerability will be closely monitored throughout the study.

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in Advanced Solid Tumors