Actively Recruiting
A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer
Led by Bristol-Myers Squibb · Updated on 2026-04-21
234
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BMS-986500 as a treatment alone for advanced solid tumors and in combination with other drugs for advanced breast cancer previously treated with CDK4/6 inhibitors. This early phase 1 trial aims to study the safety and dosing of BMS-986500 and understand how it behaves in the body. The study is sponsored by Bristol-Myers Squibb and includes participants with various advanced cancers such as breast and ovarian cancer. The study involves several parts including dose escalation and dose expansion phases for both monotherapy and combination therapy. Participants may receive BMS-986500 alone or in combination with palbociclib and fulvestrant, given at specified doses on certain days. One part focuses on ovarian cancer with a specific genetic marker (CCNE1 amplification). The trial monitors how participants respond to these treatments over time. Participants will be closely monitored for side effects, including serious and dose-limiting toxicities, during and after treatment up to 28 days from the last dose. The study also measures drug levels in the blood for up to about 2 years. Assessments include tracking adverse events, treatment tolerability, and pharmacodynamics. Participation is expected to last through various treatment phases with ongoing safety and response evaluations.
CONDITIONS
Brief Title
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Participants must have a confirmed diagnosis of locally advanced, unresectable, or metastatic solid tumor malignancy.
- Participants must have measurable disease according to RECIST v1.1 criteria.
- Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- For Part 2A only, participants must have CCNE1-amplified ovarian cancer.
You will not qualify if you...
- Participants must not have active brain metastases.
- Participants must not have impaired cardiac function or clinically significant cardiac disease.
- Participants must not have bleeding disorders or a history of significant bleeding within the prior 3 months.
- Participants must not have Grade 2 or higher peripheral neuropathy.
- Other protocol-defined inclusion and 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.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive BMS-986500 as monotherapy or in combination with other drugs to treat advanced solid tumors.
Multiple visits per cycle for dosing and assessments
Duration - Up to 28 days from last dose
Participants are monitored for safety and outcomes up to 28 days after the last dose of treatment.
1 to 2 visits for safety assessments
Trial Site Locations
Total: 21 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Actively Recruiting
2
Providence St. Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
3
Marin Cancer Care
Greenbrae, California, United States, 94904
Actively Recruiting
4
Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
6
Local Institution - 0008
Aurora, Colorado, United States, 80045
Not Yet Recruiting
7
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
10
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
11
Northwell Health-Cancer Institute
New Hyde Park, New York, United States, 11042
Actively Recruiting
12
Local Institution - 0011
New York, New York, United States, 10016
Not Yet Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
START Dallas Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
15
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
16
Odense Universitetshospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
17
Local Institution - 0025
Copenhagen, Denmark, 2100
Not Yet Recruiting
18
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
19
Kansai Medical University Hospital
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
20
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
21
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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