Recruiting NCT06067841
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986460.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
Overview
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.
Interventions
- Drug BMS-986460
Specified dose on specified days.
Primary outcome measures
- Number of participants with adverse events (AEs) [Time frame: Up to 112 weeks]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to 112 weeks]
- Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria [Time frame: Up to 28 days]
- Number of participants with AEs leading to study intervention discontinuation [Time frame: Up to 104 weeks]
- Number of deaths [Time frame: Up to 108 weeks]
Secondary outcome measures (6)
- Maximum concentration (Cmax) [Time frame: Up to 13 weeks]
- Time of maximum concentration (Tmax) [Time frame: Up to 13 weeks]
- Area under the plasma concentration-time curve (AUC) [Time frame: Up to 13 weeks]
- Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate [Time frame: Up to 108 weeks]
- Number of participants with soft tissue response [Time frame: Up to 108 weeks]
- Duration of response (DOR) [Time frame: Up to 108 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- Stanford Cancer Center — Palo Alto
- Florida Cancer Specialists Sarasota Drug Development Unit — Sarasota
- Dana-Farber Cancer Institute — Boston
- Memorial Sloan Kettering Cancer Center — New York
- Duke Cancer Institute — Durham
- Local Institution - 0006 — San Antonio
- NEXT Oncology — San Antonio
- Fred Hutchinson Cancer Center — Seattle
Identifiers
NCT: NCT06067841 · CA125-1008 · 2024-513987-24 · U1111-1307-2450