Tests BMS-986523 alone and with other cancer drugs in advanced solid tumors
Tests the drug BMS-986523, alone or combined, in adults with advanced solid cancers.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
Key facts
- Where
- Baltimore, Fairfax, San Antonio, and West Valley City, United StatesSee the 4 sites
- Phase
- Phase 1/2
Where in United States
- Johns Hopkins HospitalBaltimore, United StatesTaking people
- NEXT VirginiaFairfax, United StatesTaking people
- NEXT OncologySan Antonio, United StatesTaking people
- START Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07223047
- Record updated
- 28 May 2026
- Original description
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 malignanciesRead full original descriptionShow less
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
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
Inclusion: 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: Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN); Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment; Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted; Participants must not have untreated central nervous system (CNS) metastases; Other protocol-defined Inclusion/Exclusion criteria apply.