A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants ≥ 18 years of age with frontline or R/R NHL. * Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \> 1.5 cm in the transverse diameter). * Participants must accept and follow pregnancy prevention plan. Exclusion Criteria: * Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2. * Participants with an inability to compl…
Interventions
- DrugBMS-986458
Specified dose on specified days.
- DrugRituximab
Specified dose on specified days.
- DrugGlofitamab/Obinutuzumab
Specified dose on specified days
- DrugMosunetuzumab
Specified dose on specified days
- DrugEpcoritamab
Specified dose on specified days
- DrugGolcadomide
Specified dose on specified days
Locations (67)
- Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
- City of Hope Comprehensive Cancer CenterDuarte, California
- Local Institution - 0068Jacksonville, Florida
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Mayo Clinic in Rochester, MinnesotaRochester, Minnesota