CC-94676 for Metastatic Castration-Resistant Prostate Cancer

Not currently recruiting at 46 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Celgene

Must be taking: Androgen deprivation therapy

Must not be taking: Androgen receptor degraders

Disqualifiers: Concurrent malignancy, Venous thromboembolism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CC-94676 for men with a specific type of prostate cancer that has spread and does not respond to standard hormone therapies. The goal is to assess the safety, effectiveness, and patient tolerance of this treatment. Men diagnosed with prostate cancer that continues to grow despite hormone therapy and who have tried at least one other hormone treatment are suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CC-94676 has been tested in patients with advanced prostate cancer and is well tolerated. Patients who tried other treatments did not experience severe side effects, indicating manageable safety.

The data comes from studies involving patients whose prostate cancer did not respond to testosterone-lowering treatments. Even in these challenging cases, the treatment showed promise.

CC-94676 remains under study, but these early findings suggest it could be a safe option. Always consult a doctor to learn more about the trial and its potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for metastatic castration-resistant prostate cancer, which often involve hormone therapy or chemotherapy, CC-94676 represents a novel approach by targeting specific proteins involved in cancer cell growth. Researchers are excited about CC-94676 because it has a unique mechanism of action that could potentially overcome resistance seen with current therapies. Additionally, this treatment is being explored in combination with other compounds, CC1083611 and CC1083610, which might enhance its effectiveness and offer a new multi-pronged attack against the cancer. This innovative approach could lead to more effective treatments with fewer side effects, giving hope to patients who have limited options.

What evidence suggests that this trial's treatments could be effective for metastatic castration-resistant prostate cancer?

Research has shown that CC-94676, a treatment in this trial, has promising effects against tumors in patients with advanced prostate cancer who have tried other treatments. Studies found that patients tolerated the side effects of this drug well. It also proved effective for those who had already received many other prostate cancer treatments. This suggests that CC-94676 could benefit people who haven't had success with previous treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join this trial. They must have tried at least one other treatment for their condition, be in good physical shape (able to perform daily activities without significant limitations), and not have any other active cancers or recent serious blood clots.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through a lab test.

I am fully active or restricted in physically strenuous activity but can do light work.

My prostate cancer has worsened despite hormone therapy and at least one other treatment.

Exclusion Criteria

I haven't had a serious blood clot in the last 3 months.

I do not have any uncontrolled infections, severe lab abnormalities, or major psychiatric illnesses.

I do not have another cancer needing treatment or any cancer active in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-94676 to evaluate safety, tolerability, and preliminary efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CC-94676

Trial Overview The study tests the safety and initial effectiveness of three experimental drugs: CC1083610, CC1083611, and CC-94676. These are given to men whose prostate cancer has worsened despite hormone therapy and previous treatments.

How Is the Trial Designed?

Group I: Administration of CC-94676, CC1083611, and CC1083610 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04001-8/fulltext

Safety and clinical activity of BMS-986365 (CC-94676), a ... BMS-986365 showed antitumor activity in heavily pretreated patients with mCRPC, all previously exposed to at least one ARPI. Abstract.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39293515/

Safety and clinical activity of BMS-986365 (CC-94676), a dual ... BMS-986365 was well tolerated, with a manageable safety profile, and demonstrated activity in heavily pretreated patients with mCRPC with potentially higher ...

3. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-prostate-cancer/160006-aua-2025-bms-986365-cc-94676-a-dual-androgen-receptor-ligand-directed-degrader-and-antagonist-for-heavily-pre-treated-patients-with-metastatic-castration-resistant-prostate-cancer-results-from-additional-exploratory-analyses.html

AUA 2025: BMS-986365 (CC-94676), A Dual Androgen ... Manish Patel presented the results of an exploratory analysis evaluating BMS-986365 (CC-94676), a dual androgen receptor ligand-directed ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.134

First-in-human phase 1 study of CC-94676, a first-in-class ... CC-94676 shows promising and prolonged clinical activity in heavily pretreated mCRPC pts who progressed on abi, enza, and chemo with activity seen in pts with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04428788

Study to Evaluate the Safety and Tolerability of CC-94676 ... The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04428788

NCT04428788 | Study to Evaluate the Safety and ... The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant ...

7. bmsstudyconnect.com bmsstudyconnect.com/se/en/clinical-trials/NCT04428788.html

Study to Evaluate the Safety and Tolerability of CC-94676 in ... The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic ...