What is BMS-986517 studying for advanced solid tumors?

BMS-986517 is being studied to evaluate its safety and tolerability in adults with advanced solid tumors. Researchers aim to understand how this new drug affects tumor response and patient safety over time. The study is sponsored by Bristol-Myers Squibb and helps gather important early data about this treatment.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 years and older with advanced solid tumors such as NSCLC, HNSCC, TNBC, or HR+/HER2- breast cancer may be eligible. Participants must have a good performance status and measurable disease. People with untreated brain metastases or recent other cancers may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07160725

A Phase 12a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors

Led by Bristol-Myers Squibb · Updated on 2026-05-15

315

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a phase 12a, open-label study to evaluate the safety and tolerability of BMS-986517 in adults with advanced solid tumors. This first-in-human trial focuses on participants with measurable advanced, unresectable, or metastatic solid tumors such as non-small cell lung cancer NSCLC, head and neck squamous cell carcinoma HNSCC, triple-negative breast cancer TNBC, and hormone receptor-positivehuman epidermal growth factor receptor 2-negative HRHER2- breast cancer. Participants receive BMS-986517 as monotherapy at specified doses on designated days. The study includes multiple experimental parts and cohorts with randomized allocation, and no blinding is used. The treatment period and safety assessments extend up to approximately two years, while tumor response and duration of response are followed for up to about three years. During the study, participants undergo regular evaluations including monitoring for adverse events, dose-limiting toxicities, and serious adverse events. Tumor response is measured by RECIST v1.1 criteria, and blood samples are collected to study drug concentration and anti-drug antibodies. The study monitors participant safety closely and records any adverse events leading to discontinuation or death. Total participation can last several years depending on individual response and follow-up.

CONDITIONS

Brief Title

A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have an ECOG performance status of 0 to 1.
Participants must have measurable disease by RECIST v1.1.
Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Participants must be adults aged 18 years or older.

You will not qualify if you...

Participants must not have untreated CNS metastases unless treated and neurologically stable.
Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years.
Participants must not have a history of serious recurrent infections.
Participants must not have impaired cardiac function or a history of severe heart disease.
Other protocol-defined inclusion/exclusion criteria apply.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

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