Study on [225Ac]Ac-PSMA-R2 for Treating PSMA-positive Prostate Cancer, With or Without Previous 177Lu-PSMA Treatment

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05983198

Provider View

This clinical trial is testing a new drug, [225Ac]Ac-PSMA-R2, to see if it is safe and effective in treating prostate cancer that has spread and is positive for PSMA. The study includes patients who have and have not received a similar treatment before.

Patient Parameters

Program Overview

This study is for men with prostate cancer that has spread and is either sensitive to hormones or resistant to castration. Participants must have had previous cancer treatments and show positive results on a specific PET scan. The study aims to find out if the new drug, [225Ac]Ac-PSMA-R2, is safe and can help reduce tumors.

Description

The study is divided into three groups, each with two parts: dose escalation and dose expansion. In the dose escalation part, researchers will determine the safest and most effective dose of [225Ac]Ac-PSMA-R2. This will be done by gradually increasing the dose and monitoring for side effects. Once the best dose is found, the dose expansion part will begin, where more patients will receive the drug to see how well it works against prostate cancer. Decisions about dose increases will be made by the study team based on safety data. The goal is to find out if the drug can help shrink tumors in patients with prostate cancer that has spread.

Eligibility Criteria

Inclusion Criteria

  • Must have prostate cancer that shows positive results on a specific PET scan.
  • Cancer must be progressing despite previous treatments.
  • Must have good organ function.
  • Must have had surgery to remove the testicles or be on hormone therapy, and have received or not received a similar treatment before, depending on the group.

Exclusion Criteria

  • Cannot have taken any other experimental drugs within 28 days before starting the study treatment.
  • Cannot have had any cancer treatments within 28 days before starting the study treatment.
  • Cannot have uncontrolled pain or other issues that would prevent them from completing imaging tests.
  • Cannot have a history of cancer spreading to the brain or spinal cord issues.
  • Cannot have had a heart attack or serious heart problems within six months before joining the study.
  • Cannot have had another type of cancer in the past three years that could affect life expectancy or interfere with the study.

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