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Trial Title:
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
NCT ID:
NCT06067841
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Castration-resistant prostate cancer
Adenocarcinoma of the prostate
Prostatic Neoplasms Castration-Resistant
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986460
Description:
Specified dose on specified days.
Arm group label:
Administration of BMS-986460
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sandhya Srinivas, Site 0004
Phone:
650-725-2078
Facility:
Name:
Florida Cancer Specialists Sarasota Drug Development Unit
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Manish Patel, Site 0007
Phone:
941-377-9993
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atish Choudhury, Site 0003
Phone:
000-000-0000
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dana Rathkopf, Site 0002
Phone:
646-422-4379
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Armstrong, Site 0001
Phone:
919-668-8797
Facility:
Name:
Local Institution - 0006
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Withdrawn
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Sommerhalder, Site 0008
Phone:
210-580-9500
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Hawley, Site 0005
Phone:
206-606-2284
Start date:
October 18, 2023
Completion date:
January 16, 2029
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06067841
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06067841.html