Home › Cancer (all types) › NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in 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

Who can join

Ages 18 and older · All sexes

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.

About the study

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

What is being tested

• BMS-986500 (drug)
• Palbociclib (drug)
• Fulvestrant (drug)

Sponsor: Bristol-Myers Squibb · Participants: 234 · Started: Aug 1, 2025

Contact the study team

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · Phone: 855-907-3286

Official record on ClinicalTrials.gov — NCT06997029

Locations in the U.S.

Conditions

• Cancer (all types)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.