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

NCT ID: NCT06476808

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2028-12-19

Brief Summary

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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.

Detailed Description

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Conditions

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High-grade Serous Ovarian Carcinoma (HGSOC) Uterine Serous Carcinoma (USC) Non-small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Dose Escalation

Group Type EXPERIMENTAL

BMS-986463

Intervention Type DRUG

Specified dose on specified days

Arm 2: Dose Expansion

Group Type EXPERIMENTAL

BMS-986463

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986463

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Valkyrie Clinical Trials

Los Angeles, California, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Local Institution - 0045

Columbus, Ohio, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0046

Dallas, Texas, United States

Site Status NOT_YET_RECRUITING

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Local Institution - 0031

Villejuif, Val-de-Marne, France

Site Status NOT_YET_RECRUITING

Local Institution - 0036

Borddeaux Cedex, , France

Site Status NOT_YET_RECRUITING

Local Institution - 0035

Lyon, , France

Site Status NOT_YET_RECRUITING

Local Institution - 0032

Rozzano, Milano, Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0033

Milan, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0041

Avda.Pio XII 36,, , Spain

Site Status NOT_YET_RECRUITING

Local Institution - 0042

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Canada France Italy Spain

Central Contacts

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BMS Study Connect www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Anastasia Martynova, Site 0003

Role: primary

310-226-2905

David Berz, Site 0006

Role: primary

424-535-1874

Martin Gutierrez, Site 0001

Role: primary

551-996-5863

Site 0045

Role: primary

Site 0046

Role: primary

Yvette Drew, Site 0026

Role: primary

604-877-6000

Amit Oza, Site 0027

Role: primary

416-946-2818

Diane Provencher, Site 0028

Role: primary

514 890-8000

Susie Lau, Site 0024

Role: primary

5143408222ext23114

Site 0031

Role: primary

Site 0036

Role: primary

Site 0035

Role: primary

Site 0032

Role: primary

Site 0033

Role: primary

Site 0041

Role: primary

Site 0042

Role: primary

Related Links

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Other Identifiers

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CA231-0000

Identifier Type: -

Identifier Source: org_study_id

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