NCT06764771PHASE1Recruiting
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Bristol-Myers Squibb
Start Date
3/25/2025
Completion Date
10/15/2027
Summary
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
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BMS-986488
DRUG
Adagrasib
DRUG
Cetuximab
DRUG
Nivolumab
Conditions
Advanced Malignant Tumors
Locations
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Local Institution - 0020
Allentown, Pennsylvania 18103
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138
United States
Local Institution - 0025
Dallas, Texas 75390
United States
Local Institution - 0031
Brisbane, Queensland 4029
Australia
BC Cancer Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
Local Institution - 0015
Montreal, Quebec H2X 0A9
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec G1J 1Z4
Canada