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

NCT06476808 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CA231-00002025-523067-38
• Study Type: interventional
• Target: 240
• Locations: 5 countries
• Sites: 17

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  Up to 108 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 108 weeks

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

  Up to 108 weeks

• Number of participants with AEs leading to discontinuation

  Up to 108 weeks

• Number of participants with AEs leading to death

  Up to 108 weeks

Secondary Outcomes (6)

• Maximum observed concentration (Cmax)

  Up to 104 weeks

• Area under the concentration-time curve (AUC)

  Up to 104 weeks

• Time of maximum observed concentration (Tmax)

  Up to 104 weeks

• Objective response rate (ORR)

  Up to 104 weeks

• Disease control rate (DCR)

  Up to 104 weeks

Study Arms (2)

Arm 1: Dose Escalation

EXPERIMENTAL

Drug: BMS-986463

Arm 2: Dose Expansion

EXPERIMENTAL

Drug: BMS-986463

Interventions

BMS-986463 DRUG

Specified dose on specified days

Arm 1: Dose Escalation; Arm 2: Dose Expansion

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Local Institution - 0045

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Local Institution - 0046

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Local Institution - 0049

Houston, Texas, 77054, United States

NOT YET RECRUITING

BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Local Institution - 0036

Bordeaux, Aquitaine, 33076, France

NOT YET RECRUITING

Local Institution - 0031

Villejuif, Val-de-Marne, 94800, France

NOT YET RECRUITING

Local Institution - 0035

Lyon, 69373, France

NOT YET RECRUITING

Local Institution - 0033

Milan, 20141, Italy

NOT YET RECRUITING

Local Institution - 0032

Milan, 20159, Italy

NOT YET RECRUITING

Local Institution - 0042

Barcelona, Barcelona [Barcelona], 08035, Spain

NOT YET RECRUITING

Local Institution - 0041

Avda.Pio XII 36,, 31008, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): December 19, 2028
• Study Completion (Estimated): December 19, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

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

Locations

US (6); IT (2); ES (2); CA (4); FR (3)