Study on AMO959 and Lutetium (177Lu) Vipivotide Tetraxetan with Hormone Therapy for Advanced Prostate Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07226986

Provider View

This clinical trial is testing a new combination of treatments for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study aims to evaluate the safety and effectiveness of combining AMO959 with Lutetium (177Lu) Vipivotide Tetraxetan and hormone therapy.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment combination for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study will be conducted in two phases. In the first phase, researchers will determine the safest dose of AMO959 when combined with Lutetium (177Lu) Vipivotide Tetraxetan and hormone therapy. In the second phase, the study will evaluate how well this combination works in shrinking tumors in patients who have not yet received certain chemotherapy treatments.

Description

This study is divided into two parts:

  1. Phase Ib: This part will test different doses of AMO959 to find the safest dose when combined with Lutetium (177Lu) Vipivotide Tetraxetan and hormone therapy (abiraterone or enzalutamide). Initially, participants will receive AMO959 alone, and then it will be combined with Lutetium (177Lu) Vipivotide Tetraxetan. Researchers will monitor participants closely to determine the best dose for further testing.

  2. Phase II: In this part, participants will be randomly assigned to receive the best dose of AMO959 along with Lutetium (177Lu) Vipivotide Tetraxetan and hormone therapy. The goal is to see how effective this combination is in treating prostate cancer that has not responded to previous hormone therapy but has not yet been treated with certain chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of prostate cancer.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have prostate cancer that has spread and is resistant to standard hormone therapy.
  • Must have a positive PSMA-PET scan, which is a special imaging test for prostate cancer.
  • Must have low testosterone levels or be on hormone therapy to lower testosterone.
  • Must have shown progression of prostate cancer while on hormone therapy, based on specific criteria such as rising PSA levels or new cancer lesions.

Exclusion Criteria

  • Cannot have received certain cancer treatments, like radiation or chemotherapy, within 28 days before starting the study.
  • Cannot have been treated with any PSMA-targeted therapies before.
  • Cannot have other serious medical conditions that might interfere with the study.
  • If there is a history of cancer spread to the brain, it must have been treated and stable without the need for steroids.

Locations

FACILITYZIPCITYSTATE
Rio Grande Urology79912El PasoTexas
Utah Intermountain Medical Center84107MurrayUtah

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