BMS-986500 alone or with other therapies for advanced solid tumors
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
This trial will test whether BMS-986500 by itself or combined with palbociclib and fulvestrant can help adults with advanced solid tumors, including breast and ovarian cancers, especially after CDK4/6 inhibitor treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 21 sites (Birmingham, Alabama and 20 other locations) |
| Trial ID | NCT06997029 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label trial testing BMS-986500 as monotherapy in adults with advanced, unresectable, or metastatic solid tumors and as combination therapy in selected breast and ovarian cancer cohorts. The study uses dose-escalation and expansion cohorts to define safety, tolerability, and an appropriate dose, with tumor response measured by RECIST v1.1. Part 2A specifically enrolls patients with CCNE1-amplified ovarian cancer, while combination arms focus on patients previously treated with CDK4/6 inhibitors. Eligible participants must be adults with measurable disease and ECOG performance status 0–1, and the protocol excludes patients with active brain metastases, significant cardiac disease, recent major bleeding, or high-grade neuropathy.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed advanced, unresectable, or metastatic solid tumors with measurable disease and ECOG 0–1 are the main candidates, with specific cohorts for CDK4/6-pretreated breast cancer and CCNE1-amplified ovarian cancer in Part 2A.
Not a fit: Patients with active brain metastases, significant cardiac disease, recent clinically significant bleeding, Grade ≥2 peripheral neuropathy, or other protocol-defined exclusions are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option for people with advanced solid tumors and a targeted combo option for breast and CCNE1-amplified ovarian cancers after CDK4/6 therapy.
How similar studies have performed: Other early-phase targeted-agent combinations have shown preliminary activity in advanced cancers, but BMS-986500 is in early human testing and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be ≥ 18 years of age. * Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. * Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * 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 Exclusion Criteria: * Participants must not have an active brain metastasis. * Participants must not have impaired cardiac function or clinically significant cardiac disease. * Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. * Participants must not have Grade ≥ 2 peripheral neuropathy. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Birmingham, Alabama and 20 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Providence St. Jude Medical Center — Fullerton, California, United States (Recruiting)
- Marin Cancer Care — Greenbrae, California, United States (Recruiting)
- Moores Cancer Center — La Jolla, California, United States (Recruiting)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
- Local Institution - 0008 — Aurora, Colorado, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- Northwell Health-Cancer Institute — New Hyde Park, New York, United States (Recruiting)
- Local Institution - 0011 — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- START Dallas Fort Worth — Fort Worth, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- Odense Universitetshospital — Odense, Region Syddanmark, Denmark (Recruiting)
- Local Institution - 0025 — Copenhagen, Denmark (Not_yet_recruiting)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (Recruiting)
- Kansai Medical University Hospital — Hirakata, Osaka, Japan (Recruiting)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
- The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.