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Study of BMS-986500 for Advanced Solid Tumors

This study is testing a drug called BMS-986500. It's being studied alone in people with advanced solid tumors, and in combination with Palbociclib and Fulvestrant for those with advanced breast cancer that has been previously treated with CDK4/6 inhibitors. The main goal of this study is to see how safe BMS-986500 is by tracking any side effects or serious side effects. To join, you must be at least 18 years old and have a solid tumor that is advanced, cannot be removed by surgery, or has spread. You also need to have measurable disease. The current status of this study is unclear, and it plans to enroll about 234 participants.

Study design
This is an interventional study with a planned enrollment of 234 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects and serious side effects up to Day 28 from the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06997029

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~234 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:BMS-986500PalbociclibFulvestrant

At a glance

Recruiting sites
19 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Dose Limiting Toxicities (DLTs)
Measured over Up to Day 28 From Last Dose
+4 more outcomes measured

Conditions

Advanced Solid Tumor
Advanced Breast Cancer
Advanced Ovarian Cancer

Explore related trials

Breast CarcinomaMalignant Ovarian NeoplasmSolid NeoplasmG1/S-Specific Cyclin-E1

Where it's being run

21 sites across 13 states
California4
New York4
Texas2
Tokyo2
Alabama1
Colorado1
Massachusetts1
Missouri1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants With Dose Limiting Toxicities (DLTs)Up to Day 28 From Last Dose
  • Number of Participants With Adverse Events (AEs)Up to Day 28 From Last Dose
  • Number of Participants With Serious Adverse Events (SAEs)Up to Day 28 From Last Dose
  • Number of Participants With AEs Leading to DiscontinuationUp to Day 28 From Last Dose
  • Number of Participants With TEAEs Leading to DeathUp to Day 28 From Last Dose