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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: BMS-986463

Study type: Interventional

Funder types: Industry

Identifiers

NCT06476808

2025-523067-38 (Other Identifier)

CA231-0000

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Arm 1: Dose Escalation

Experimental group

Treatment:

Drug: BMS-986463

Arm 2: Dose Expansion

Experimental group

Treatment:

Drug: BMS-986463