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

Phase 1

Recruiting

• Conditions: High-grade Serous Ovarian Carcinoma (HGSOC); Uterine Serous Carcinoma (USC); Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: BMS-986463

• Registration Number: NCT06476808
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Study Start: 2024-09-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2028-12-19
• Study Completion: 2028-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1: Dose Escalation	BMS-986463	-
Arm 2: Dose Expansion	BMS-986463	-

Primary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events (SAEs)	Up to 108 weeks
Number of participants with adverse events (AEs)	Up to 108 weeks
Number of participants with AEs leading to discontinuation	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 death	Up to 108 weeks

Secondary Outcome Measures

Name	Time	Method
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
Duration of response (DOR)	Up to 104 weeks
Maximum observed concentration (Cmax)	Up to 104 weeks
Area under the concentration-time curve (AUC)	Up to 104 weeks

Trial Locations

Locations (6)

BC Cancer Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

John Theurer Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Local Institution - 0027; 🇨🇦 Toronto, Ontario, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada