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NCT Number: 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

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

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Key information

Conditions

Advanced Solid Malignancies Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer (NSCLC) Pancreatic Diseases Pancreatic Ductal Adenocarcinoma (PDAC) Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

BC Cancer Vancouver, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986523

Drug

Specified dose on specified days

Gemcitabine

Drug

Specified dose on specified days

Nab-paclitaxel

Drug

Specified dose on specified days

Cetuximab

Drug

Specified dose on specified days

Pembrolizumab

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 3 years

  3. Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria

    Time frame: Up to 3 years

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 3 years

  5. Number of deaths

    Time frame: Up to 3 years

Secondary outcomes

  1. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.

    Time frame: Up to 3 years

  2. Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.

    Time frame: Up to 3 years

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 3 years

  4. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 3 years

  5. Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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