Recruiting
Phase 1

BMS-986463

Sponsor:

Bristol-Myers Squibb

Code:

NCT06476808

Conditions

High-grade Serous Ovarian Carcinoma (HGSOC)

Uterine Serous Carcinoma (USC)

Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986463

Study Details

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)

Study ID

NCT06476808

Start date

Sep 6, 2024

Status verified date

Jul, 2026

Completion date

Dec 19, 2028

Anticipated

Primary completion date

Dec 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Dose Escalation

experimental: Arm 2: Dose Expansion

Interventions

BMS-986463

Specified dose on specified days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Anastasia Martynova, Site 0003

310-226-2905

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

David Berz, Site 0006

424-535-1874

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Martin Gutierrez, Site 0001

551-996-5863

BC Cancer Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Yvette Drew, Site 0026

604-877-6000

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Amit Oza, Site 0027

416-946-2818

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Diane Provencher, Site 0028

514 890-8000

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Susie Lau, Site 0024

5143408222ext23114

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-20.