BI-1808 as a Single Agent and With Pembrolizumab in Treatment of Advanced Malignancies
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort,
open-label study of BI-1808, as a single agent and in combination with pembrolizumab in
subjects with advanced malignancies, whose disease has progressed after standard therapy.
For the purpose of this study, subjects with advanced malignancies includes subjects with
advanced solid tumors (where iRECIST can be applied for efficacy assessment) and subjects
with cutaneous T-cell lymphoma (CTCL), specifically Sézary Syndrome (SS) and mycosis
fungoides (MF).
The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A
and B.
All subjects participating in the trial will complete a follow-up portion of the trial and an
End of Treatment (EOT) Visit 30 days (±3 days) after their last dose of BI-1808.