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Clinical Trials in the USA / NCT06067841
Recruiting Phase 1

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

NCT06067841 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1
Started
2023-10-18
Last updated
2026-08-10

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

BMS-986460

BMS-986460: Specified dose on specified days.

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Number of participants with adverse events (AEs) — Up to 112 weeks
  • Number of participants with serious adverse events (SAEs) — Up to 112 weeks
  • Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria — Up to 28 days
  • Number of participants with AEs leading to study intervention discontinuation — Up to 104 weeks
  • Number of deaths — Up to 108 weeks

Trial sites (15)

FacilityCityRegionStatus
Stanford Cancer Center Palo Alto California Recruiting
Florida Cancer Specialists Sarasota Drug Development Unit Sarasota Florida Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Local Institution - 0006 San Antonio Texas Withdrawn
NEXT Oncology San Antonio Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Local Institution - 0009 Toronto Ontario Not Yet Recruiting
Local Institution - 0011 Montreal Quebec Not Yet Recruiting
Local Institution - 0018 Bordeaux Aquitaine Not Yet Recruiting
Centre Leon Berard Lyon Cedex08 Auvergne-Rhône-Alpes Recruiting
Institut Paoli-Calmettes Marseille Nan Recruiting
Gustave Roussy Villejuif Val-de-Marne Recruiting
Local Institution - 0017 Paris France Not Yet Recruiting

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A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma Recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Recruiting
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) Recruiting
A Study to Assess Deucravacitinib Safety in Pregnancy Recruiting

Other trials for the same condition

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC Active, not recruiting
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer Recruiting
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06067841 on ClinicalTrials.gov ↗ ← All trials in the USA