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

RECRUITINGPhase 1Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2023-10-18
Est. completion2029-08-24
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations8 sites

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer

Locations8 sites

Stanford Cancer Center
Palo Alto, California, 94304
Sandhya Srinivas, Site 0004650-725-2078
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, 34232
Manish Patel, Site 0007941-377-9993
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Atish Choudhury, Site 0003000-000-0000
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Dana Rathkopf, Site 0002646-422-4379
Duke Cancer Institute
Durham, North Carolina, 27710
Andrew Armstrong, Site 0001919-668-8797

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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