First-in-human testing of BMS-986517 in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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.
* For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
* For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
* For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center
  Orange, California, United States 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

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

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.