Study on the Safety of TD001 for Men with Advanced Prostate Cancer

Sponsor: T.O.A.D. Oncology SA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07258407

Provider View

This clinical trial is testing a new treatment called TD001, designed to target prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to determine if TD001 is safe and how well it works in reducing cancer activity.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of TD001, a new treatment targeting prostate-specific membrane antigen (PSMA) in men with advanced prostate cancer that no longer responds to hormone therapy. Researchers will assess how the body processes the drug and its potential to reduce cancer activity.

Description

This study is the first time TD001 is being tested in humans. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study is conducted in multiple centers and is divided into two phases. The first phase will determine the best dose of TD001 to use in the second phase, where more patients will receive the treatment to further evaluate its safety and effectiveness. Different dosing schedules may be tested to find the most effective approach. The study will help optimize the dose for patients with this type of prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and agree to participate by signing a consent form.
  • Have advanced prostate cancer that expresses PSMA and has shown progression despite treatment.
  • Have at least one measurable tumor that can be tracked during the study.
  • Have good organ function as determined by medical tests.
  • Have had surgery to remove the testicles or be on ongoing hormone therapy to lower testosterone levels.
  • Have previously been treated with at least one drug that targets androgen receptors.

Exclusion Criteria

  • Have received certain radioactive treatments for cancer within the last 6 months.
  • Have had any cancer treatment, including experimental drugs, within the last 28 days.
  • Have known allergies to TD001 or similar drugs.
  • Have breathing difficulties at rest, require continuous oxygen, or have a history of lung inflammation.

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