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
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer, Sarcoma
- 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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| BC Cancer - Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Hortaleza | Spain | Not yet recruiting |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.