Clinical trial NCT06067841: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: Prostate Cancer
Castration-resistant prostate cancer
Adenocarcinoma of the prostate
Prostatic Neoplasms Castration-Resistant
Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 112 weeks
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 112 weeks
measure: Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
timeFrame: Up to 28 days
measure: Number of participants with AEs leading to study intervention discontinuation
timeFrame: Up to 104 weeks
measure: Number of deaths
timeFrame: Up to 212 weeks
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Up to 13 weeks
measure: Time of maximum concentration (Tmax)
timeFrame: Up to 13 weeks
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 13 weeks
measure: Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate
timeFrame: Up to 108 weeks
measure: Number of participants with soft tissue response
timeFrame: Up to 108 weeks
measure: Duration of response (DOR)
timeFrame: Up to 108 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Sarasota
country: United States
facility: Florida Cancer Specialists Sarasota Drug Development Unit
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: San Antonio
country: United States
facility: Local Institution - 0006
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: