Actively Recruiting
Phase 1/2a Study of BMS-986517 as Monotherapy in Adults with Advanced Solid Tumors
Led by Bristol-Myers Squibb · Updated on 2026-03-24
315
Participants Needed
19
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of a new drug called BMS-986517 in adults with advanced solid tumors. It is a first-in-human, open-label phase 1/2a study focusing on participants with cancers such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and hormone receptor-positive/HER2-negative breast cancer. Participants must have measurable disease and a good overall health status to take part. Participants will receive BMS-986517 as a monotherapy with doses given on specified days. The study does not describe other treatment groups or comparators. The trial is designed to monitor effects and side effects over time to assess the drug's safety profile. During the study, researchers will track the number of participants experiencing adverse events, serious adverse events, dose-limiting toxicities within the first 21 days, treatment discontinuations due to side effects, and deaths related to adverse events. The observation period may extend up to approximately two years. Participants will undergo regular evaluations to monitor their health status and treatment effects throughout the study.
CONDITIONS
Official 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.
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 prior malignancy active within 2 years before treatment.
- Participants must not have a history of serious recurrent infections.
- Participants must not have impaired cardiac function or 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
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
Local Institution - 0021
Orange, California, United States, 92868
Not Yet 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
Frequently Asked Questions
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