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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

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