Stopped: Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions
Phase 1b/Phase 2 Umbrella Study; open-label, multi-center, parallel group study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. Phase1b of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 portion. Phase 2 of each sub-study will evaluate the anti-tumor activity of the combination. Sub-Study A is active, not recruiting, ongoing participants are still receiving treatment in Phase 1, Phase 2 will not be initiated. Sub-study B is complete. All participants have discontinued treatment and any additional follow up required by protocol.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)
Timeframe: Day 1 up to Day 28 of Cycle 1
Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR)
Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy
Phase 1b of Sub-Study B: Percentage of Participants With DLT
Timeframe: Day 1 up to Day 21 of Cycle 1
Phase 2 Sub-Study B: Objective Response Rate
Timeframe: From the date of first CR or PR until the date of the first documentation of PD, death, or start of new anticancer therapy (maximum of 21 months)