A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

April 13, 2026 updated by: Bristol-Myers Squibb

A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver
        • Contact:
          • Yvette Drew, Site 0026
          • Phone Number: 604-877-6000
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Amit Oza, Site 0027
          • Phone Number: 416-946-2818
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Susie Lau, Site 0024
          • Phone Number: 5143408222ext23114
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
          • Diane Provencher, Site 0028
          • Phone Number: 514 890-8000
  • France
      • Lyon, France, 69373
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • Italy
      • Milan, Italy, 20141
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
      • Milan, Italy, 20159
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
  • Spain
      • Avda.Pio XII 36,, Spain, 31008
        • Not yet recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0042
        • Contact:
          • Site 0042
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Contact:
          • Anastasia Martynova, Site 0003
          • Phone Number: 310-226-2905
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials
        • Contact:
          • David Berz, Site 0006
          • Phone Number: 424-535-1874
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Martin Gutierrez, Site 0001
          • Phone Number: 551-996-5863
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Houston, Texas, United States, 77054
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
  • Participants must have an unresectable/metastatic carcinoma.

Exclusion Criteria

  • Participants must not have Leptomeningeal 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 had any prior radiation therapy within 2 weeks prior to start of study treatment.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Dose Escalation
Drug: BMS-986463
Specified dose on specified days
Experimental: Arm 2: Dose Expansion
Drug: BMS-986463
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 108 weeks
Up to 108 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 108 weeks
Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 108 weeks
Up to 108 weeks
Number of participants with AEs leading to discontinuation
Time Frame: Up to 108 weeks
Up to 108 weeks
Number of participants with AEs leading to death
Time Frame: Up to 108 weeks
Up to 108 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to 104 weeks
Up to 104 weeks
Area under the concentration-time curve (AUC)
Time Frame: Up to 104 weeks
Up to 104 weeks
Time of maximum observed concentration (Tmax)
Time Frame: Up to 104 weeks
Up to 104 weeks
Objective response rate (ORR)
Time Frame: Up to 104 weeks
Up to 104 weeks
Disease control rate (DCR)
Time Frame: Up to 104 weeks
Up to 104 weeks
Duration of response (DOR)
Time Frame: Up to 104 weeks
Up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

December 19, 2028

Study Completion (Estimated)

December 19, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA231-0000
  • 2025-523067-38 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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