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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor Advanced Breast Cancer Advanced Ovarian Cancer

Keywords

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cancer oncology solid tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A Monotherapy Dose Escalation

Group Type EXPERIMENTAL

BMS-986500

Intervention Type DRUG

Specified dose of specified days

Part 1B Combination Dose Escalation

Group Type EXPERIMENTAL

BMS-986500

Intervention Type DRUG

Specified dose of specified days

Palbociclib

Intervention Type DRUG

Specified dose on specified days

Fulvestrant

Intervention Type DRUG

Specified dose on specified days

Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

Group Type EXPERIMENTAL

BMS-986500

Intervention Type DRUG

Specified dose of specified days

Part 2A Monotherapy Dose Expansion

Group Type EXPERIMENTAL

BMS-986500

Intervention Type DRUG

Specified dose of specified days

Part 2B Combination Dose Expansion

Group Type EXPERIMENTAL

BMS-986500

Intervention Type DRUG

Specified dose of specified days

Palbociclib

Intervention Type DRUG

Specified dose on specified days

Fulvestrant

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986500

Specified dose of specified days

Intervention Type DRUG

Palbociclib

Specified dose on specified days

Intervention Type DRUG

Fulvestrant

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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IBRANCE® PD 0332991 FASLODEX®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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