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A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

NCT06764771 · Bristol-Myers Squibb
In plain English

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Official title
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
About this study
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Eligibility criteria
Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). * Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. * Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. * Participants must have measurable disease per RECIST v1.1. Exclusion Criteria: * Untreated central nervous system (CNS) metastases. * Leptomeningeal metastasis (carcinomatous meningitis). * Impaired cardiac function or clinically significant cardiac disease. * For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). \- Other protocol-defined inclusion/exclusion criteria apply.
Study design
Enrollment target: 437 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-25
Estimated completion: 2027-10-15
Last updated: 2026-06-03
Interventions
Drug: BMS-986488Drug: AdagrasibDrug: CetuximabDrug: Nivolumab
Primary outcomes
  • Number of participants with Adverse Events (AEs) (Until the end of the Safety Follow-up period (up to approximately 100 days after last dose))
  • Number of participants with Serious AEs (SAEs) (Until the end of the Safety Follow-up period (up to approximately 100 days after last dose))
  • Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria (From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days))
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (8)
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Local Institution - 0020Active Not Recruiting
Allentown, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer CenterRecruiting
Germantown, Tennessee, United States
Local Institution - 0025Withdrawn
Dallas, Texas, United States
Local Institution - 0031Active Not Recruiting
Brisbane, Queensland, Australia
Local Institution - 0032Active Not Recruiting
Vancouver, British Columbia, Canada
Local Institution - 0015Not Yet Recruiting
Montreal, Quebec, Canada
Local Institution - 0016Active Not Recruiting
Québec, Quebec, Canada
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors · TrialPath