Phase 12a Study of BI-1206 Combined with Pembrolizumab for Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are investigating the combination of BI-1206, a monoclonal antibody targeting CD32b, with pembrolizumab in adults with advanced solid tumors. This Phase 12a trial aims to determine the appropriate dosing and evaluate the safety of these treatments given together. The study includes patients with advanced solid tumors like uveal melanoma and non-small cell lung cancer NSCLC, assessing disease response and tolerability. Participants receive BI-1206 either intravenously IV or subcutaneously SC every three weeks, along with a fixed 200 mg IV dose of pembrolizumab every three weeks. The trial has two main parts Phase 1 dose escalation to find the recommended doses for IV and SC administration, and Phase 2a where patients with uveal melanoma and NSCLC receive the combination at the selected SC dose. Those showing clinical benefit after three treatment cycles may continue therapy every three weeks for up to two years or until disease progression. During the study, participants will undergo evaluations to monitor side effects, lab tests, and physical exams to assess treatment safety. Researchers will also measure drug levels, immune responses, and receptor occupancy over up to two years. Tumor biopsies and imaging will be performed to evaluate disease status. The study involves regular visits aligned with treatment cycles and includes long-term follow-up for monitoring adverse events and treatment effects.

A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors