First-in-human testing of BMS-986517 in advanced solid tumors
A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors
This trial will test the experimental drug BMS-986517 in adults with advanced, unresectable or metastatic solid tumors such as non-small cell lung cancer, head and neck cancer, and certain breast cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 19 sites (Irvine, California and 18 other locations) |
| Trial ID | NCT07160725 on ClinicalTrials.gov |
What this trial studies
This is an open-label, first-in-human phase 1/2a trial primarily focused on the safety and tolerability of BMS-986517 in participants with advanced solid tumors. Participants receive BMS-986517 and are monitored for adverse events, pharmacokinetics, and tumor response using RECIST v1.1. Eligible participants must have histologically or cytologically confirmed unresectable or metastatic solid tumors, measurable disease, and an ECOG performance status of 0–1. Key exclusions include untreated CNS metastases, concurrent active malignancy requiring treatment, serious recurrent infections, and significant cardiac impairment.
Who should consider this trial
Good fit: Adults with confirmed advanced, unresectable or metastatic solid tumors (including NSCLC, HNSCC, triple-negative breast cancer, or HR+/HER2- breast cancer), measurable disease by RECIST v1.1, and ECOG 0–1 are the intended candidates.
Not a fit: Patients with untreated CNS metastases, active concurrent malignancy, a history of serious recurrent infections, significant cardiac impairment, or poor performance status are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, BMS-986517 could provide a new treatment option that controls tumor growth with an acceptable safety profile for some patients with advanced solid tumors.
How similar studies have performed: This is a first-in-human trial so BMS-986517 is untested in people, although related targeted or immunomodulatory approaches have produced benefit in some solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer. Exclusion Criteria: * Participants must not have untreated CNS metastases. Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). * Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. * Participants must not have history of serious recurrent infections. * Participants must not have impaired cardiac function or history of severe heart disease. * Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
Irvine, California and 18 other locations
- Local Institution - 0033 — Irvine, California, United States (Not_yet_recruiting)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Local Institution - 0021 — Orange, California, United States (Not_yet_recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Sanford Cancer Center — Sioux Falls, South Dakota, United States (Recruiting)
- START - Dallas Fort Worth — Fort Worth, Texas, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- Herlev and Gentofte Hospital — Copenhagen, Capital Region, Denmark (Recruiting)
- Odense Universitetshospital — Odense, Region Syddanmark, Denmark (Recruiting)
- Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
- Local Institution - 0026 — Málaga, Andalusia, Spain (Not_yet_recruiting)
- Local Institution - 0022 — Badalona, Barcelona [Barcelona], Spain (Not_yet_recruiting)
- Local Institution - 0024 — Barcelona, Barcelona [Barcelona], Spain (Not_yet_recruiting)
- Local Institution - 0025 — Pamplona, Navarre, Spain (Not_yet_recruiting)
- Local Institution - 0027 — Madrid, Spain (Not_yet_recruiting)
- Local Institution - 0023 — Madrid, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.