A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).
• Participants must, for Arm D, have a PD-L1 expression (≥50%).
• Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.
Locations
United States
Maryland
Local Institution - 0009
NOT_YET_RECRUITING
Baltimore
Texas
NEXT Oncology
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Local Institution - 0002
NOT_YET_RECRUITING
Vancouver
Spain
Local Institution - 0006
NOT_YET_RECRUITING
Badalona
Local Institution - 0008
NOT_YET_RECRUITING
Hortaleza
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2028-10-13
Participants
Target number of participants: 252
Treatments
Experimental: Arm A
Experimental: Arm B
Experimental: Arm C
Experimental: Arm D
Experimental: Arm E
Experimental: Arm F
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb