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

NCT07223047 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA256-00012025-523547-35
• Study Type: interventional
• Target: 252
• Locations: 3 countries
• Sites: 8

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)

Keywords

Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Cancer; Lung Cancer; Kirsten rat sarcoma viral oncogene homolog (KRAS)

Outcome Measures

Primary Outcomes (5)

• 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) criteria

  Up to 3 years

• Number of participants with AEs leading to discontinuation

  Up to 3 years

• Number of deaths

  Up to 3 years

Secondary Outcomes (5)

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

  Up to 3 years

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

  Up to 3 years

• Maximum observed plasma concentration (Cmax)

  Up to 3 years

• Time of maximum observed plasma concentration (Tmax)

  Up to 3 years

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

  Up to 3 years

Study Arms (6)

Arm A

EXPERIMENTAL

Drug: BMS-986523

Arm B

EXPERIMENTAL

Drug: BMS-986523

Arm C

EXPERIMENTAL

Drug: BMS-986523

Arm D

EXPERIMENTAL

Drug: BMS-986523; Drug: Pembrolizumab

Arm E

EXPERIMENTAL

Drug: BMS-986523; Drug: Cetuximab

Arm F

EXPERIMENTAL

Drug: BMS-986523; Drug: Gemcitabine; Drug: Nab-Paclitaxel

Interventions

BMS-986523 DRUG

Specified dose on specified days

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Gemcitabine DRUG

Specified dose on specified days

Arm F

Nab-Paclitaxel DRUG

Specified dose on specified days

Arm F

Cetuximab DRUG

Specified dose on specified days

Arm E

Pembrolizumab DRUG

Specified dose on specified days

Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (8)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Local Institution - 0006

Badalona, Barcelona [Barcelona], 08916, Spain

NOT YET RECRUITING

Local Institution - 0008

Hortaleza, Madrid, 28050, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasms; Lung Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Cetuximab; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 13, 2028
• Study Completion (Estimated): October 13, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CA (2); ES (2); US (4)