Lu-PSMA-617 for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Melissa Lumish, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Melissa Lumish

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.

Research Team

Melissa Lumish, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for individuals with liver cancer that tests positive for a protein called PSMA. Specific details about who can join or reasons why someone might not be eligible are not provided in the information given.

Inclusion Criteria

I have had one treatment for my liver cancer that cannot be surgically removed.

My blood counts and kidney function are within normal ranges.

Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I have had Y90 treatment for liver cancer.

I had major surgery less than 3 months ago and haven't fully recovered.

I do not have untreated brain metastases or carcinomatous meningitis.

Treatment Details

Interventions

• Lu-PSMA-617 (Radioligand Therapy)

Trial Overview The study is examining the effects of a drug named 177Lu-PSMA-617 on patients with PSMA-positive liver cancer to determine its safety and effectiveness.

Participant Groups

Group I: Lu-PSMA-617 Experimental Treatment 1 Intervention

Participants will receive 177Lu-PSMA-617 7.4 GBq (200 mCi) once every 6 weeks. 177Lu-PSMA-617 is a radiopharmaceutical which will be administered intravenously (IV).

Who Is Running the Clinical Trial?

Melissa Lumish

Lead Sponsor

Trials

1

Recruited

10+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania