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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06997029

Enrollment

234

Registered

2025-05-30

Start date

2025-08-01

Completion date

2028-12-14

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer, Advanced Ovarian Cancer, Advanced Solid Tumor

Keywords

cancer, oncology, solid tumor

Brief summary

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.

Interventions

DRUGBMS-986500

Specified dose of specified days

DRUGPalbociclib

Specified dose on specified days

DRUGFulvestrant

Specified dose on specified days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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 Discontinuation	Up to Day 28 From Last Dose
Number of Participants With TEAEs Leading to Death	Up to Day 28 From Last Dose

Secondary

Measure	Time frame
Maximum Observed Serum Concentration (Cmax) of BMS-986500	Up to Approximately 2 Years
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500	Up to Approximately 2 Years
Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500	Up to Approximately 2 Years

Countries

Denmark, Japan, United States

Contacts

CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

Clinical.Trials@bms.com855-907-3286

CONTACTFirst line of the email MUST contain NCT # and Site #.

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026