NCT07223047PHASE1, PHASE2Recruiting
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
Bristol-Myers Squibb
Start Date
11/25/2025
Completion Date
10/13/2028
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 Criteria
Age Range: 18 years to No maximum
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 central nervous system (CNS) metastases.
* 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 a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
* Other protocol-defined Inclusion/Exclusion criteria apply.
Interventions
DRUG
BMS-986523
DRUG
Gemcitabine
DRUG
Nab-Paclitaxel
DRUG
Cetuximab
DRUG
Pembrolizumab
Conditions
Advanced Solid MalignanciesNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)
Locations
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
NEXT Oncology
San Antonio, Texas 78229
United States
START Mountain Region
West Valley City, Utah 84119
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
BC Cancer Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Local Institution - 0006
Badalona, Barcelona [Barcelona] 08916
Spain
Local Institution - 0008
Hortaleza, Madrid 28050
Spain