Phase 2 Study of 177Lu-PSMA-617 for Treating Advanced Kidney Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06964958

Provider View

This clinical trial is testing a new treatment called 177Lu-PSMA-617 to see if it is safe and effective for patients with advanced kidney cancer that shows a specific marker called PSMA.

Patient Parameters

Program Overview

The study is exploring the use of 177Lu-PSMA-617, a type of targeted radiation therapy, to treat patients with advanced clear cell renal cell carcinoma (ccRCC) that is PSMA-positive. This treatment aims to deliver radiation directly to cancer cells to help destroy them. Although this drug is not yet approved for kidney cancer, it is approved for advanced prostate cancer. Participants will undergo various tests and scans, receive up to 6 cycles of the treatment over about 8 months, and be monitored for up to 5 years after treatment ends. The study involves about 24 participants and is supported by Novartis Pharmaceuticals.

Description

This study is being conducted to test the safety and effectiveness of a new treatment called 177Lu-PSMA-617 for patients with advanced kidney cancer that has a specific marker known as PSMA. The treatment uses targeted radiation to attack cancer cells. Although not yet approved for kidney cancer, it is approved for prostate cancer. Participants will be screened for eligibility and will undergo various tests, including blood tests and imaging scans. They will receive the treatment in cycles over approximately 8 months and will be followed up every 6 months for up to 5 years after stopping the treatment. The study is supported by Novartis Pharmaceuticals, which provides the drug and funding.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced or metastatic kidney cancer with a clear cell component, including certain subtypes.
  • Must have at least one tumor that can be measured by scans.
  • Aged 18 years or older.
  • Previously received at least one immune therapy and one tyrosine kinase inhibitor.
  • Have at least one PSMA-positive tumor and no PSMA-negative tumors.
  • In good general health with an ECOG performance status of 0 to 2.
  • Adequate blood and organ function based on specific lab tests.
  • Agree to use effective birth control during the study and for a period after the last dose.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Previously received PSMA-targeted therapy.
  • Had recent radiotherapy or experimental cancer treatments.
  • Have untreated or unstable brain metastases.
  • Have not recovered from side effects of previous cancer treatments, except for hair loss.
  • Have allergies to similar drugs.
  • Have serious medical conditions that could interfere with the study.
  • Pregnant or breastfeeding women.

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