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

Recruiting now · Phase 1

Conditions studied: Advanced Malignant Tumors

In brief

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.

Key facts

Study ID

NCT06764771

Run by

Bristol-Myers Squibb

People needed

437

Starts

2025-03-25

Expected to finish

2027-10-15

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• The West Clinic, PLLC dba West Cancer Center — Germantown, Tennessee, United States (enrolling)
• BC Cancer Vancouver — Vancouver, British Columbia, Canada (enrolling)
• Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus — Québec, Quebec, Canada (enrolling)
• Local Institution - 0031 — Brisbane, Queensland, Australia
• Local Institution - 0020 — Allentown, Pennsylvania, United States
• Local Institution - 0015 — Montreal, Quebec, Canada
• Local Institution - 0025 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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