Actively Recruiting
A Phase 1/2a, 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
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1/2a, 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-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) 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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 3 years
Participants receive specified doses of the study drug BMS-986517 on specified days as part of the trial treatment.
Trial Site Locations
Total: 19 locations
1
Local Institution - 0033
Irvine, California, United States, 92612
Not Yet Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States, 92868-3201
Actively Recruiting
4
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
6
START - Dallas Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
7
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
8
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
9
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
10
Herlev and Gentofte Hospital
Copenhagen, Capital Region, Denmark, 2730
Actively Recruiting
11
Odense Universitetshospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
12
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
13
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
14
Local Institution - 0026
Málaga, Andalusia, Spain, 29010
Not Yet Recruiting
15
Local Institution - 0022
Badalona, Barcelona [Barcelona], Spain, 08916
Not Yet Recruiting
16
Local Institution - 0024
Barcelona, Barcelona [Barcelona], Spain, 08035
Not Yet Recruiting
17
Local Institution - 0025
Pamplona, Navarre, Spain, 31008
Not Yet Recruiting
18
Local Institution - 0027
Madrid, Spain, 28040
Not Yet Recruiting
19
Local Institution - 0023
Madrid, Spain, 28050
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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