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Clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMS-986458, in monotherapy and in combination with antilymphoma agents, in participants with relapsed/refractory non-Hodgkin's lymphoma (R/R NHL).
THE STUDY HAS 2 PARTS, DOSE ESCALATION (PART A) AND DOSE EXPANSION (PART B). DEPENDING ON WHEN YOU AGREE TO PARTICIPATE IN THE STUDY, YOU MAY BE SELECTED TO PARTICIPATE IN EITHER PART. THE OBJECTIVE OF PART A IS TO DETERMINE THE OPTIMAL DOSE OF BMS-986458 THAT CAN BE SAFELY ADMINISTERED TO PATIENTS WITH R/R NHL. THE OBJECTIVE OF PART B IS TO EVALUATE THE SELECTED SAFE DOSE(S) OF BMS-986458 IN A LARGER GROUP OF PARTICIPANTS.
Technical Summary
- PHASE 1, MULTICENTER, OPEN-LABEL, DOSE-FINDING, PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, PHARMACODYNAMICS AND PRELIMINARY EFFICACY OF BMS-986458, IN MONOTHERAPY AND IN COMBINATION WITH ANTILYMPHOMA AGENTS, IN PARTICIPANTS WITH RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA (R/R NHL).
- Code EudraCT: 2023-506654-20-00
- Protocol number: CA123-1000
- Promoter: ABX-CRO advanced pharmaceutical services - Forschungsgesellschaft m.b.H.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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