What side effects are associated with this type of intervention?

Common treatments for castration-resistant prostate cancer (CRPC) include androgen receptor inhibitors like enzalutamide, apalutamide, and darolutamide, which can cause fatigue, falls, and central nervous system effects. Abiraterone combined with prednisone is associated with hypertension, hypokalemia, and liver function abnormalities. Taxane-based chemotherapies such as docetaxel and cabazitaxel often result in neutropenia, neuropathy, and alopecia. These treatments aim to manage CRPC but come with a range of side effects that should be carefully monitored.

What prior FDA approvals exist?

Several FDA-approved treatments for castration-resistant prostate cancer (CRPC) include androgen receptor signaling inhibitors and taxane-based chemotherapies. Enzalutamide, apalutamide, and darolutamide are androgen receptor inhibitors that block multiple steps in the androgen receptor signaling pathway, improving metastasis-free survival. Abiraterone acetate, combined with prednisone, inhibits CYP17, a critical enzyme in androgen production. Taxane-based chemotherapies like docetaxel and cabazitaxel disrupt microtubule function, inhibiting cancer cell division. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, targets PSMA-positive metastatic CRPC. These treatments have significantly advanced the management of CRPC.

What other types of research exist?

Promising novel alternatives to CC-94676 for prostate cancer patients in 2024 include: 1) Pembrolizumab or Dostarlimab for patients with metastatic CRPC with dMMR or high TMB. 2) Lutetium Lu 177 vipivotide tetraxetan for PSMA-positive metastatic CRPC. 3) Bipolar Androgen Therapy (BAT) for resensitizing CRPC to androgen-directed therapies. These therapies target specific pathways and have shown efficacy in selected patient populations.

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CC-94676 for Metastatic Castration-Resistant Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have histologically or cytologically confirmed adenocarcinoma of the prostate

Must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Must not have

Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness

Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

Summary

This trial is testing a new drug for men with prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include typical reactions from cancer medications such as nausea, fatigue, allergic responses, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on each drug's profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer diagnosis was confirmed through a lab test.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have been treated with medication that targets the androgen receptor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT)

Maximum tolerated dose (MTD)

Non-tolerated dose (NTD)

+1 more

Secondary outcome measures

Complement H50

Duration of response (DOR)

Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of CC-94676, CC1083611, and CC1083610Experimental Treatment3 Interventions

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments primarily target the androgen receptor pathway, crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels, slowing cancer progression. Androgen receptor signaling inhibitors, such as enzalutamide and abiraterone, block androgen receptor activation or androgen synthesis, respectively, further inhibiting cancer growth. Immunotherapy, like sipuleucel-T, stimulates the immune system to attack cancer cells. Novel agents, potentially similar to CC-94676, may target specific molecular pathways involved in castration-resistant prostate cancer, offering new avenues for treatment. Understanding these mechanisms helps tailor therapies to individual patient needs, improving outcomes and managing resistance.

New therapies for castration-resistant prostate cancer: efficacy and safety.