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 (BMS)

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Malignancies

Treatments: Drug: Pembrolizumab; Drug: Cetuximab; Drug: Gemcitabine; Drug: Nab-Paclitaxel; Drug: BMS-986523

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223047

CA256-0001

2025-523547-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 6 patient groups

Arm A

Experimental group

Treatment:

Drug: BMS-986523

Arm B

Experimental group

Treatment:

Drug: BMS-986523

Arm C

Experimental group

Treatment:

Drug: BMS-986523

Arm D

Experimental group

Treatment:

Drug: BMS-986523

Drug: Pembrolizumab

Arm E

Experimental group

Treatment:

Drug: BMS-986523

Drug: Cetuximab

Arm F

Experimental group

Treatment:

Drug: BMS-986523

Drug: Nab-Paclitaxel

Drug: Gemcitabine