Language: BG BG
← Back to results
Recruiting Phase 1 NCT06997029

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

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumor Advanced Breast Cancer Advanced Ovarian Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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/Exclusion criteria apply.
Interventions
BMS-986500
DRUG
Palbociclib
DRUG
Fulvestrant
DRUG
Locations 21
Denmark (2)
Local Institution - 0025
Copenhagen
NOT_YET_RECRUITING
Odense Universitetshospital
Odense , Region Syddanmark
Annette Kodahl, Site 0024
Japan (4)
National Cancer Center Hospital
Chuo-ku , Tokyo
Takafumi Koyama, Site 0022
Kansai Medical University Hospital
Hirakata , Osaka
Toshio Shimizu, Site 0020
National Cancer Center Hospital East
Kashiwa , Chiba
Chikako Funasaka, Site 0021
The Cancer Institute Hospital of JFCR
Koto-ku , Tokyo
Shigehisa Kitano, Site 0023
United States (15)
Local Institution - 0008
Aurora , Colorado
NOT_YET_RECRUITING
University of Alabama at Birmingham
Birmingham , Alabama
Mehmet Akce, Site 0001
Dana-Farber Cancer Institute
Boston , Massachusetts
Joyce Liu, Site 0006
Roswell Park Cancer Institute
Buffalo , New York
Christos Fountzilas, Site 0014
START Dallas Fort Worth
Fort Worth , Texas
Henry Xiong, Site 0018
Providence St. Jude Medical Center
Fullerton , California
Yung Lyou, Site 0003
Marin Cancer Care
Greenbrae , California
Cyrus Mazidi, Site 0013
Moores Cancer Center
La Jolla , California
Peter Vu, Site 0009
Dartmouth-Hitchcock Medical Center
Lebanon , New Hampshire
Lionel Lewis, Site 0002
Northwell Health-Cancer Institute
New Hyde Park , New York
Local Institution - 0011
New York , New York
NOT_YET_RECRUITING
Memorial Sloan Kettering Cancer Center
New York , New York
Ezra Rosen, Site 0012
Hoag Memorial Hospital Presbyterian
Newport Beach , California
Monica Mita, Site 0010
NEXT Oncology
San Antonio , Texas
David Sommerhalder, Site 0007
Washington University School of Medicine
St Louis , Missouri
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.08.2025
Completion date
14.12.2028
Registry ID
NCT06997029
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.