A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Malignancies; Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC)
• Interventions: Drug: BMS-986523; Drug: Cetuximab; Drug: Gemcitabine; Drug: Pembrolizumab; Drug: Nab-Paclitaxel

• Registration Number: NCT07223047
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-29
• Study First Submitted QC: 2025-10-29
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31
• Study Start: 2025-11-26
• Primary Completion: 2028-10-13
• Study Completion: 2028-10-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BMS-986523	-
Arm B	BMS-986523	-
Arm E	Cetuximab	-
Arm F	Gemcitabine	-
Arm C	BMS-986523	-
Arm D	BMS-986523	-
Arm D	Pembrolizumab	-
Arm E	BMS-986523	-
Arm F	BMS-986523	-
Arm F	Nab-Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria	Up to 3 years
Number of participants with AEs leading to discontinuation	Up to 3 years
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 deaths	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.	Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.	Up to 3 years
Maximum observed plasma concentration (Cmax)	Up to 3 years
Time of maximum observed plasma concentration (Tmax)	Up to 3 years
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))	Up to 3 years

Trial Locations

Locations (5)

Local Institution - 0001; 🇺🇸 San Antonio, Texas, United States

Local Institution - 0007; 🇺🇸 Salt Lake City, Utah, United States

Local Institution - 0011; 🇺🇸 Fairfax, Virginia, United States

Local Institution - 0002; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0010; 🇨🇦 Toronto, Ontario, Canada