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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

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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