Fact CheckerSign in

NCT07223047RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
252 (estimated)
First submitted
29 Oct 2025
Start date
25 Nov 2025
Primary completion date
13 Oct 2028
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT07223047
EudraCT number
2025-523547-35

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 252
  • From 25 Nov 2025 to the primary completion date, 13 Oct 2028
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Other illness

  • 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.

Other

  • Participants must not have untreated central nervous system (CNS) metastases.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
BC Cancer - Vancouver
Coordinator of this site? Confirm its status
VancouverCanadaRecruiting
-
Coordinator of this site? Confirm its status
BadalonaSpainNot yet recruiting
-
Coordinator of this site? Confirm its status
HortalezaSpainNot yet recruiting
Johns Hopkins Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
NEXT Virginia
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
NEXT Oncology
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
START Mountain Region
Coordinator of this site? Confirm its status
West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.