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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067841
• Other study ID #: CA125-1008
• Status: Recruiting
• Phase: Phase 1
• Start date: October 18, 2023
• Est. completion date: January 16, 2029

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 16, 2029
• Est. primary completion date: January 5, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• BMS-986460
Specified dose on specified days.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Duke Cancer Institute	Durham	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford Cancer Center	Palo Alto	California
United States	Local Institution - 0006	San Antonio	Texas
United States	NEXT Oncology	San Antonio	Texas
United States	Florida Cancer Specialists Sarasota Drug Development Unit	Sarasota	Florida
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to 112 weeks
Primary	Number of participants with serious adverse events (SAEs)		Up to 112 weeks
Primary	Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria		Up to 28 days
Primary	Number of participants with AEs leading to study intervention discontinuation		Up to 104 weeks
Primary	Number of deaths		Up to 212 weeks
Secondary	Maximum concentration (Cmax)		Up to 13 weeks
Secondary	Time of maximum concentration (Tmax)		Up to 13 weeks
Secondary	Area under the plasma concentration-time curve (AUC)		Up to 13 weeks
Secondary	Number of participants with a confirmed prostate specific antigen decline of = 30% from baseline response rate		Up to 108 weeks
Secondary	Number of participants with soft tissue response		Up to 108 weeks
Secondary	Duration of response (DOR)		Up to 108 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting