A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

May 1, 2024 updated by: Bristol-Myers Squibb

A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site#

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford Cancer Center
        • Contact:
          • Sandhya Srinivas, Site 0004
          • Phone Number: 650-725-2078
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists Sarasota Drug Development Unit
        • Contact:
          • Manish Patel, Site 0007
          • Phone Number: 941-377-9993
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Atish Choudhury, Site 0003
          • Phone Number: 000-000-0000
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Dana Rathkopf, Site 0002
          • Phone Number: 646-422-4379
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke Cancer Institute
        • Contact:
          • Andrew Armstrong, Site 0001
          • Phone Number: 919-668-8797
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
        • Contact:
          • David Sommerhalder, Site 0008
          • Phone Number: 210-580-9500
      • San Antonio, Texas, United States, 78229
        • Withdrawn
        • Local Institution - 0006
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Jessica Hawley, Site 0005
          • Phone Number: 206-606-2284

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
  • Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)

Exclusion Criteria:

  • Participant must not have history of brain metastases.
  • Participant must not have impaired cardiac function or clinically significant cardiac disease.
  • Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of BMS-986460
Drug: BMS-986460
Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 112 weeks
Up to 112 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 112 weeks
Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Time Frame: Up to 28 days
Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
Time Frame: Up to 104 weeks
Up to 104 weeks
Number of deaths
Time Frame: Up to 212 weeks
Up to 212 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax)
Time Frame: Up to 13 weeks
Up to 13 weeks
Time of maximum concentration (Tmax)
Time Frame: Up to 13 weeks
Up to 13 weeks
Area under the plasma concentration-time curve (AUC)
Time Frame: Up to 13 weeks
Up to 13 weeks
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
Time Frame: Up to 108 weeks
Up to 108 weeks
Number of participants with soft tissue response
Time Frame: Up to 108 weeks
Up to 108 weeks
Duration of response (DOR)
Time Frame: Up to 108 weeks
Up to 108 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

January 5, 2027

Study Completion (Estimated)

January 16, 2029

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA125-1008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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