Study on ONC-392 and Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Advanced Prostate Cancer

Sponsor: OncoC4, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05682443

Provider View

This clinical trial is testing a new combination treatment for patients with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to determine if the combination of ONC-392 and Lutetium Lu 177 Vipivotide Tetraxetan is safe and effective in slowing down the progression of the disease.

Patient Parameters

Program Overview

The purpose of this Phase 2 study is to evaluate the safety and effectiveness of combining ONC-392 with Lutetium Lu 177 Vipivotide Tetraxetan in patients with metastatic castration-resistant prostate cancer (mCRPC). These patients have cancer that has continued to grow despite previous treatments targeting androgen receptors and up to two lines of taxane chemotherapy. Participants will be randomly assigned to receive either the new combination treatment or the standard treatment with Lutetium Lu 177 Vipivotide Tetraxetan alone. The study will take place at multiple centers and is open-label, meaning both the researchers and participants know which treatment is being given.

Description

The goal of this clinical trial is to test the safety and effectiveness of a new treatment combination for advanced prostate cancer that has spread and is resistant to hormone therapy. The study will compare two groups of patients: one group will receive the new combination of ONC-392 and Lutetium Lu 177 Vipivotide Tetraxetan, while the other group will receive the standard treatment with Lutetium Lu 177 Vipivotide Tetraxetan alone. The main questions the study aims to answer are whether the new combination is safe and whether it can help slow down the progression of the cancer.

Participants in the experimental group will receive ONC-392 through an IV infusion for up to 9 cycles (about one year) along with Lutetium Lu 177 Vipivotide Tetraxetan for up to 6 cycles. Those in the control group will receive the standard treatment with Lutetium Lu 177 Vipivotide Tetraxetan for up to 6 cycles. The study will monitor the participants' health and the progression of their cancer to determine the effectiveness of the treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to understand and sign a consent form.
  • Must have a good performance status (ECOG 0 or 1).
  • Must have a life expectancy of more than 6 months.
  • Must have confirmed prostate adenocarcinoma.
  • Must have a positive PSMA PET scan showing cancer spread.
  • Must have had an orchiectomy or ongoing hormone therapy with low testosterone levels.
  • Must have tried at least one second-generation AR-targeting drug.
  • Must have had up to two taxane chemotherapy treatments or be unable or unwilling to have them.
  • Must have progressive mCRPC based on specific criteria like rising PSA levels or new bone lesions.
  • Must have at least one metastatic lesion visible on recent imaging.
  • Must have adequate organ function.
  • Can be on bisphosphonate or denosumab treatment for at least 30 days before the study.
  • Must use effective birth control if they or their partners are of childbearing potential.

Exclusion Criteria

  • Have not recovered from side effects of previous cancer treatments to a mild level.
  • Have had recent cancer treatment with certain drugs or therapies.
  • Have allergies to the study drugs or similar medications.
  • Are receiving other cancer treatments or investigational therapies.
  • Have had a blood transfusion within 14 days before starting the study.
  • Have PSMA-negative lesions of a certain size in specific areas.
  • Have had certain types of radiation therapy within 6 months before the study.
  • Have untreated or unstable brain metastases.
  • Have a superscan on a bone scan.
  • Have symptoms or signs of spinal cord compression.
  • Have serious medical conditions that could interfere with the study.
  • Have another active cancer, except for certain skin cancers.
  • Are taking high doses of steroids or other immunosuppressive medications.

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