A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Lung Cancer; Breast Cancer
• Interventions: Drug: BMS-986507; Drug: Osimertinib; Drug: Pembrolizumab; Drug: Nivolumab

• Registration Number: NCT06618287
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Study Start: 2025-02-04
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-10
• Last Update Posted: 2025-10-14
• Primary Completion: 2026-12-16
• Study Completion: 2028-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	BMS-986507	-
Group A	Osimertinib	-
Group B	BMS-986507	-
Group B	Pembrolizumab	-
Group C	BMS-986507	-
Group C	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to 3 years
Number of participants with serious adverse events (SAEs)	Up to 3 years
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera	Up to 3 years
Number of participants with AEs leading to discontinuation	Up to 3 years
Number of participants with AEs leading to death	Up to 3 years
Number of DLTs that occur during the DLT evaluation period	Up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax)	Up to 3 years
Time of maximum observed concentration (Tmax)	Up to 3 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to 3 years
Area under the serum concentration-time curve within a dosing interval (AUC(TAU))	Up to 3 years
Objective response rate (ORR)	Up to 1 year

Trial Locations

Locations (48)

Local Institution - 0077; 🇫🇷 Nice, Alpes-Maritimes, France

H.R.U Málaga - Hospital General; 🇪🇸 Málaga, Spain

Local Institution - 0066; 🇺🇸 Birmingham, Alabama, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

Local Institution - 0065; 🇺🇸 Iowa City, Iowa, United States

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

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0052; 🇺🇸 Portland, Oregon, United States

Local Institution - 0014; 🇺🇸 Pittsburgh, Pennsylvania, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

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