New hope for men with Hard-to-Treat prostate cancer?
NCT ID NCT06067841
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This early-stage trial is testing a new drug called BMS-986460 in 140 men with metastatic castration-resistant prostate cancer, a type that no longer responds to standard hormone therapy. The main goals are to check the drug's safety and find the right dose, while also looking for signs that it might shrink tumors or lower PSA levels. Participants must have already tried at least one other hormone treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BMS-986460
- What this could lead to
- If successful, this could lead to a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
- What could go wrong
- This is an early Phase 1 trial with only 140 participants, focused on safety. The drug may not prove effective or could have significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Leon Berard
RECRUITINGLyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Duke Cancer Institute
RECRUITINGDurham, North Carolina, 27710, United States
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Florida Cancer Specialists Sarasota Drug Development Unit
RECRUITINGSarasota, Florida, 34232, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Gustave Roussy
RECRUITINGVillejuif, Val-de-Marne, 94800, France
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Institut Paoli-Calmettes
RECRUITINGMarseille, Nan, 13009, France
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Local Institution - 0006
WITHDRAWNSan Antonio, Texas, 78229, United States
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Local Institution - 0009
NOT_YET_RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Local Institution - 0011
NOT_YET_RECRUITINGMontreal, Quebec, H2X 0A9, Canada
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Local Institution - 0017
NOT_YET_RECRUITINGParis, 75015, France
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Local Institution - 0018
NOT_YET_RECRUITINGBordeaux, Aquitaine, 33076, France
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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Stanford Cancer Center
RECRUITINGPalo Alto, California, 94304, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?