RECRUITING

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

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Conditions

Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancercanceroncologysolid tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-01
Study Completion:2028-12-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06997029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be ≥ 18 years of age.
  2. * Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
  3. * Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. * Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  5. * For Part 2A only, participants must have CCNE1-amplified ovarian cancer
  1. * Participants must not have an active brain metastasis.
  2. * Participants must not have impaired cardiac function or clinically significant cardiac disease.
  3. * Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
  4. * Participants must not have Grade ≥ 2 peripheral neuropathy.
  5. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center, www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain he NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0001
Birmingham, Alabama, 35294-3300
United States
Local Institution - 0003
Fullerton, California, 92835
United States
Marin Cancer Care
Greenbrae, California, 94904
United States
Local Institution - 0009
La Jolla, California, 92093
United States
Local Institution - 0010
Newport Beach, California, 92663
United States
Local Institution - 0008
Aurora, Colorado, 80045
United States
Local Institution - 0006
Boston, Massachusetts, 02215
United States
Local Institution - 0004
Saint Louis, Missouri, 63110
United States
Local Institution - 0002
Lebanon, New Hampshire, 03756
United States
Local Institution - 0014
Buffalo, New York, 14263
United States
Local Institution - 0011
New York, New York, 10016
United States
Local Institution - 0012
New York, New York, 10021
United States
NEXT Oncology
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2028-12-14

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2028-12-14

Terms related to this study

Keywords Provided by Researchers

  • cancer
  • oncology
  • solid tumor

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Advanced Breast Cancer
  • Advanced Ovarian Cancer