Study on Dosimetry, Dose Optimization, and Efficacy of Ac-225 Rosopatamab Tetraxetan in Patients with PSMA PET-Positive Castration-Resistant Prostate Cancer

Sponsor: Convergent Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06549465

Provider View

This clinical trial is testing a new treatment for prostate cancer that has spread and is resistant to hormone therapy. The study involves a special type of radiation treatment targeting cancer cells that show up on a specific PET scan.

Patient Parameters

Program Overview

This study is divided into three parts to test the safety and effectiveness of a new treatment for prostate cancer that has spread and is resistant to hormone therapy. The treatment uses a radioactive antibody called rosopatamab tetraxetan, which targets cancer cells that are visible on a PSMA PET scan. In Part 1, participants receive a single dose to see how the treatment spreads in the body. In Part 2, participants are randomly assigned to receive different doses to find the best one. In Part 3, participants who have had a specific previous treatment will receive increasing doses to find the safest and most effective dose. Throughout the study, participants will have regular check-ups, including blood tests, heart monitoring, scans, and physical exams.

Eligibility Criteria

Inclusion Criteria

  • Have prostate cancer that has spread and is resistant to hormone therapy, showing progression by:
    • Rising PSA levels in the blood.
    • Growth of cancer in soft tissues or bones.
    • New cancer spots on a PSMA PET scan.
  • Have cancer that has spread to other parts of the body, confirmed by scans.
  • Have cancer that shows up on a PSMA PET scan.
  • Have tried hormone therapy and at least one other treatment like enzalutamide or abiraterone.

Part 3 Only:

  • Have had previous treatment with Lu-177-PSMA therapy.
  • May have had one type of chemotherapy, but it's not required.

Exclusion Criteria

  • Have a type of bone scan that shows too much activity.
  • Have another cancer that is growing or needs treatment, except for prostate cancer.
  • Have had certain chemotherapy or treatments like PARP inhibitors.
  • Are taking blood thinners or anti-inflammatory drugs and cannot stop if needed.

Part 2 Only:

  • Have had chemotherapy for prostate cancer that is resistant to hormone therapy.
  • Have had certain radioactive treatments or PSMA-targeted therapies.

Part 3 Only:

  • Have had PSMA-targeted therapies, except for Lu-177-PSMA therapy.

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