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New hope for Hard-to-Treat prostate cancer? early trial underway

NCT ID NCT04428788

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tested a new drug called CC-94676 in 131 men with metastatic castration-resistant prostate cancer, a type that has stopped responding to standard hormone therapy. The main goal was to check safety and find the right dose, while also looking for signs that the drug might shrink tumors or lower PSA levels. Results will help decide if further studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CC-94676 (also known as BMS-986365)
What this could lead to
If this drug proves safe and effective, it could offer 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 focused on safety and dosing, so it is too soon to know if CC-94676 will work. Side effects are unknown, and many drugs fail at this stage.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

131 people

The number who actually took part.

Started

Jun 2020

Finished

Oct 2025

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have histologically or cytologically confirmed adenocarcinoma of the prostate * Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: * Prior treatment with an androgen receptor (AR) degrader * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP * Clinically significant venous thromboembolism within 3 months prior to the first dose of IP * Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma neoplasm prostate cancer prostate neoplasm Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • Local Institution - 101

    San Antonio, Texas, 78229, United States

  • Local Institution - 102

    Grand Rapids, Michigan, 49546, United States

  • Local Institution - 103

    Sarasota, Florida, 34232, United States

  • Local Institution - 104

    Boston, Massachusetts, 02215, United States

  • Local Institution - 105

    New York, New York, 10065, United States

  • Local Institution - 106

    Durham, North Carolina, 27710, United States

  • Local Institution - 107

    Dallas, Texas, 75235, United States

  • Local Institution - 108

    Baltimore, Maryland, 21287, United States

  • Local Institution - 109

    New York, New York, 10032, United States

  • Local Institution - 111

    Madison, Wisconsin, 53792, United States

  • Local Institution - 112

    New York, New York, 10029, United States

  • Local Institution - 113

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 115

    Seattle, Washington, 98109, United States

  • Local Institution - 116

    Stanford, California, 94305-5826, United States

  • Local Institution - 117

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 119

    Houston, Texas, 77030, United States

  • Local Institution - 120

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 121

    Thomasville, Georgia, 31792, United States

  • Local Institution - 122

    Washington D.C., District of Columbia, 20010, United States

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