Testing BMS-986488 for advanced malignant tumors
Official title: A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Run by Bristol-Myers Squibb · NCT06764771 · Data updated 2026-11-12
This study is testing a new treatment called BMS-986488 to see if it can help people with advanced cancers feel better and fight their disease, either on its own or with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 437 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 8 sites (Hackensack, New Jersey and 7 other locations) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | October 15, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT06764771 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with specific advanced solid tumors, particularly those with KRAS G12C mutations.
✕Probably not a fit
Patients with untreated central nervous system metastases or significant cardiac issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety, tolerability, and anti-cancer activity of BMS-986488, both as a standalone treatment and in combination with other therapies, in patients with advanced malignant tumors. Participants will include those with various types of cancers, including colorectal cancer, renal cell carcinoma, and non-small cell lung cancer. The study aims to determine the effectiveness of this experimental treatment in managing these serious conditions.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors.
How similar studies have gone: Other studies have shown promise with similar approaches targeting advanced malignant tumors, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States Recruiting -
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States Recruiting -
BC Cancer Vancouver
Vancouver, British Columbia, Canada Recruiting -
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada Recruiting -
Local Institution - 0020
Allentown, Pennsylvania, United States Active not recruiting -
Local Institution - 0025
Dallas, Texas, United States Withdrawn
Show 2 more locations
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Local Institution - 0031
Brisbane, Queensland, Australia Active not recruiting -
Local Institution - 0015
Montreal, Quebec, Canada Not yet recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.