A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with pembrolizumabMasking: None (Open Label)Masking Description: open labelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1/2a, multicenter, dose-finding, consecutive-cohort, open-label trial of BI-1206 in combination with pembrolizumab in subjects with advanced solid tumors who have previously received treatment with a PD-1/PD-L1 immune checkpoint inhibitor. The trial will consist of 2 main parts: Phas...
This is a Phase 1/2a, multicenter, dose-finding, consecutive-cohort, open-label trial of BI-1206 in combination with pembrolizumab in subjects with advanced solid tumors who have previously received treatment with a PD-1/PD-L1 immune checkpoint inhibitor. The trial will consist of 2 main parts: Phase 1 (with dose escalation cohorts and selection of the RP2D), and Phase 2a (with 3 expansion cohorts at the RP2D). Subjects in each phase will initially receive 3 planned doses of therapy with BI-1206 in combination with pembrolizumab. Subjects who show clinical benefit (CR, PR or SD) at the Week 9 Visit may continue on combination therapy. Starting at Week 10, these subjects will receive infusions every 3 weeks for up to 32 additional doses or up to 2 years from first dose of BI-1206 therapy or until progression.
Tracking Information
- NCT #
- NCT04219254
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carneiro, PhD Lund University Hospital