NCT06964958

177LuPSMA in Renal Cell Carcinoma

LASER - a Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC). The name of the study drug involved in this research study is: -177Lu-PSMA-617 (a type of radioligand therapy)

Detailed description

The goal of this single-center, phase 2 research study is to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in participants with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC). 177Lu-PSMA-617 aims to deliver targeted radiation to cancer cells, leading to cell death. The U.S. Food and Drug Administration (FDA) has not approved 177Lu-PSMA-617 as a treatment option for advanced ccRCC, but the study drug is approved for advanced prostate cancer. The research study procedures include screening for eligibility, in-clinic visits, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA PET) scans. Participants will receive study treatment for up to 6 cycles, or approximately 252 days, and will be followed every 6 months for up to 5 years after discontinuing treatment. It is expected that about 24 people will take part in this research study. Novartis Pharmaceuticals Corporation is supporting this research study by supplying the study drug (177Lu-PSMA-617) and providing funding for the study.

Conditions

• Renal Cell Carcinoma
• Advanced Clear Cell Renal Cell Carcinoma
• Kidney Cancer

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	A radioligand therapy, single-dose vial, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2025-05-11
• Last updated: 2026-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study