Phase 1 Study of BHV-1530 Alone or with Cemiplimab for Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 1 study to evaluate BHV-1530 alone and in combination with cemiplimab in adults with advanced or metastatic solid tumors. This first-in-human, open-label trial aims to determine the safety, dosing, and potential benefits of BHV-1530 for patients whose cancer has progressed after standard treatments or who have no other available therapies. The study focuses on specific cancers including urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, especially those with certain genetic alterations. Participants will receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle, either alone or combined with cemiplimab given on the same schedule. The study includes dose escalation, expansion, and optimization phases to find the maximum tolerable dose and recommended dose range. Some groups may receive the drug alone, while others receive it combined with cemiplimab, with treatment continuing over multiple cycles as determined by the study protocol. During the trial, participants will have regular assessments to monitor safety and treatment effects, including tumor measurements according to RECIST 1.1 criteria and performance status evaluations. Researchers will collect tumor tissue samples, perform laboratory tests, and monitor drug levels in the blood. The main outcomes include determining optimal dosing, safety profile, and clinical benefit rates over an estimated 48 months. Participants health and response to treatment will be carefully followed throughout the study period.

A Phase 1 Study of BHV-1530 in Advanced Solid Tumors