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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986460
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring Prostate Cancer, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Center
  • Florida Cancer Specialists Sarasota Drug Development Unit
  • Dana-Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Duke Cancer Institute
  • NEXT OncologyRecruiting
  • NEXT Oncology
  • Fred Hutchinson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of BMS-986460

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Number of participants with AEs leading to study intervention discontinuation
Number of deaths

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2023
Last Updated
October 10, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT06067841
Brief Title
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Official Title
A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2023 (Anticipated)
Primary Completion Date
January 5, 2027 (Anticipated)
Study Completion Date
January 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
Keywords
Prostate Cancer, Castration-resistant prostate cancer, Adenocarcinoma of the prostate, Prostatic Neoplasms Castration-Resistant, Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of BMS-986460
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986460
Intervention Description
Specified dose on specified days.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 112 weeks
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 112 weeks
Title
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
Time Frame
Up to 28 days
Title
Number of participants with AEs leading to study intervention discontinuation
Time Frame
Up to 104 weeks
Title
Number of deaths
Time Frame
Up to 212 weeks
Secondary Outcome Measure Information:
Title
Maximum concentration (Cmax)
Time Frame
Up to 13 weeks
Title
Time of maximum concentration (Tmax)
Time Frame
Up to 13 weeks
Title
Area under the plasma concentration-time curve (AUC)
Time Frame
Up to 13 weeks
Title
Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
Time Frame
Up to 108 weeks
Title
Number of participants with soft tissue response
Time Frame
Up to 108 weeks
Title
Duration of response (DOR)
Time Frame
Up to 108 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site#
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandhya Srinivas, Site 0004
Phone
650-725-2078
Facility Name
Florida Cancer Specialists Sarasota Drug Development Unit
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Patel, Site 0007
Phone
941-377-9993
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atish Choudhury, Site 0003
Phone
000-000-0000
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Rathkopf, Site 0002
Phone
646-422-4379
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Armstrong, Site 0001
Phone
919-668-8797
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Sommerhalder, Site 0008
Phone
210-580-9500
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Hawley, Site 0005
Phone
206-606-2284

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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