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Study of BMS-986523 for Advanced Solid Cancers

This study is testing a new drug called BMS-986523, by itself and with other cancer medicines like Gemcitabine, Nab-Paclitaxel, Cetuximab, and Pembrolizumab. It's for people with advanced solid cancers that have a specific change in their KRAS gene. For some participants, their cancer must also show a certain level of PD-L1. The main goal is to see how safe these treatments are, by tracking any side effects over up to 3 years. Researchers also want to see how well the treatments work. This study plans to enroll about 252 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll about 252 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223047

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~252 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:BMS-986523GemcitabineNab-PaclitaxelCetuximabPembrolizumab

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to 3 years
+4 more outcomes measured

Conditions

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

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

8 sites across 8 states
Maryland1
Texas1
Utah1
Virginia1
British Columbia1
Ontario1
Barcelona [Barcelona]1
Madrid1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Number of participants with adverse events (AEs)Up to 3 years
  • Number of participants with serious adverse events (SAEs)Up to 3 years
  • Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteriaUp to 3 years
  • Number of participants with AEs leading to discontinuationUp to 3 years
  • Number of deathsUp to 3 years