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

NCT06997029 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CA243-00012025-524334-26-00U1111-1330-3304
• Study Type: interventional
• Target: 234
• Locations: 3 countries
• Sites: 21

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.

Conditions

Advanced Solid Tumor; Advanced Breast Cancer; Advanced Ovarian Cancer

Keywords

cancer; oncology; solid tumor

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (5)

Part 1A Monotherapy Dose Escalation

EXPERIMENTAL

Drug: BMS-986500

Part 1B Combination Dose Escalation

EXPERIMENTAL

Drug: BMS-986500; Drug: Palbociclib; Drug: Fulvestrant

Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

EXPERIMENTAL

Drug: BMS-986500

Part 2A Monotherapy Dose Expansion

EXPERIMENTAL

Drug: BMS-986500

Part 2B Combination Dose Expansion

EXPERIMENTAL

Drug: BMS-986500; Drug: Palbociclib; Drug: Fulvestrant

Interventions

BMS-986500 DRUG

Specified dose of specified days

Part 1A Monotherapy Dose Escalation; Part 1B Combination Dose Escalation; Part 1C Monotherapy Pharmacodynamic (PD) Sub-study; Part 2A Monotherapy Dose Expansion; Part 2B Combination Dose Expansion

Palbociclib DRUG

Specified dose on specified days

Also known as: IBRANCE®, PD 0332991

Part 1B Combination Dose Escalation; Part 2B Combination Dose Expansion

Fulvestrant DRUG

Specified dose on specified days

Also known as: FASLODEX®

Part 1B Combination Dose Escalation; Part 2B Combination Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (21)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

RECRUITING

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

RECRUITING

Marin Cancer Care

Greenbrae, California, 94904, United States

RECRUITING

Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Local Institution - 0008

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Northwell Health-Cancer Institute

New Hyde Park, New York, 11042, United States

RECRUITING

Local Institution - 0011

New York, New York, 10016, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

START Dallas Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Odense Universitetshospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Local Institution - 0025

Copenhagen, 2100, Denmark

NOT YET RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasms

Interventions

palbociclib; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 14, 2028
• Study Completion (Estimated): December 14, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (15); JP (4); DK (2)