Study on FOR46 and Enzalutamide for Treating Advanced Prostate Cancer

Sponsor: Rahul Aggarwal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05011188

Provider View

This clinical trial is testing a new treatment combining FOR46 and enzalutamide for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to find out if this combination can effectively reduce cancer markers and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The treatment combines a new drug, FOR46, with enzalutamide, a medication already used to treat prostate cancer. Researchers want to see if this combination can effectively lower cancer markers and improve patient outcomes. The study will also assess the safety of the treatment and how long it can control the cancer.

Description

The study is divided into two phases. In Phase 1b, researchers will determine the safest dose of FOR46 when combined with enzalutamide. In Phase 2, they will evaluate how well this combination works in reducing cancer markers and controlling the disease.

Participants will continue the treatment until their cancer progresses, they experience unacceptable side effects, or they choose to withdraw from the study. After stopping the treatment, patients will be monitored every three months to track their overall survival.

The study will measure several outcomes, including the reduction in prostate-specific antigen (PSA) levels, the response of tumors to the treatment, the duration of response, and the time until the cancer progresses. Researchers will also assess the overall survival of participants and the safety of the treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that has spread and is resistant to standard hormone therapy.
  • Cancer must have progressed after treatment with certain hormone therapies like abiraterone.
  • No previous chemotherapy for advanced prostate cancer, except in specific cases.
  • Must have measurable cancer markers or tumors.
  • Willing to undergo a biopsy of the cancer.
  • Must have low testosterone levels and continue hormone therapy if not surgically castrated.
  • No other cancer treatments within 14 days before starting the study.
  • Age 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood counts and organ function.
  • Able to understand and sign a consent form.
  • Agree to use effective contraception during the study and for 60 days after the last treatment.

Exclusion Criteria

  • Recent radiation therapy within two weeks before starting the study.
  • Previous treatment with FOR46 or similar drugs.
  • Certain types of prostate cancer that have changed to a different form.
  • Serious heart conditions or recent heart attacks.
  • History of seizures or brain conditions.
  • Lung inflammation or pneumonitis.
  • Use of high-dose steroids or immunosuppressive drugs recently.
  • Active infections requiring IV antibiotics.
  • Use of certain medications that interact with the study drugs.
  • Major surgery within 28 days before starting the study.
  • Any condition that could interfere with the study or is not in the patient's best interest to participate.
  • Psychiatric or substance abuse issues that could affect participation.

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