Phase 12a Open-Label Study of BI-1808 Alone and With Pembrolizumab in Advanced Malignancies

What this Trial Is About

Researchers are studying BI-1808, given alone or with pembrolizumab, in people with advanced cancers that have worsened after standard treatments. This early-phase trial aims to find out how safe and tolerable BI-1808 is, determine the highest dose that can be given, and select doses for future studies. The trial includes subjects with advanced solid tumors and T-cell lymphoma. Participants receive BI-1808 as an intravenous infusion every 3 weeks, either by itself or combined with pembrolizumab. The study has two main parts Phase 1 includes dose escalation to assess safety and find recommended doses, and Phase 2a expands treatment at those doses to further evaluate safety, drug behavior in the body, and preliminary effects on tumors. During the trial, participants undergo regular assessments including monitoring for side effects, blood tests to study the drugs behavior and immune effects, and imaging to measure tumor response. Safety is followed for up to two years, with evaluations of adverse events, serious adverse events, and dosing limits. The study also examines tumor response rates and progression-free survival to understand treatment impact over time.

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)