A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated cent…
Interventions
- DrugBMS-986523
Specified dose on specified days
- DrugGemcitabine
Specified dose on specified days
- DrugNab-Paclitaxel
Specified dose on specified days
- DrugCetuximab
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
Locations (8)
- Local Institution - 0009Baltimore, Maryland
- NEXT OncologySan Antonio, Texas
- START Mountain RegionWest Valley City, Utah
- NEXT VirginiaFairfax, Virginia
- Local Institution - 0002Vancouver, British Columbia
- Princess Margaret Cancer CentreToronto, Ontario