Recruiting

Phase 1

Phase 2

BMS-986523A 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

Sponsor:

Bristol-Myers Squibb

Code:

NCT07223047

Conditions

Advanced Solid Malignancies

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986523

Gemcitabine

Nab-Paclitaxel

Cetuximab

Pembrolizumab

Study Details

Brief 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

Conditions

Advanced Solid Malignancies

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07223047

Start date

Nov 25, 2025

Status verified date

May, 2026

Completion date

Oct 13, 2028

Anticipated

Primary completion date

Oct 13, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

252 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

experimental: Arm B

experimental: Arm C

experimental: Arm D

experimental: Arm E

experimental: Arm F

Interventions

BMS-986523