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NOT YET RECRUITING
NCT07828249
PHASE1

Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

This study is an open label, Phase I study investigating the safety and clinical activity of 4 IV injections of 161Tb-PSMA-1 in patients with mccRCC. This trial is divided in 2 parts: * The dose escalation part aims to assess the safety of 161Tb-PSMA-1 in up to 21 patients with mccRCC. Eligible patients will be treated with escalating activity of 161Tb-PSMA. * The extension part aims to collect preliminary clinical activity data of the proposed treatment.

Official title: PRadR2 - A Single Center, Open-label, Phase I Study Evaluating 161Tb-PSMA Therapy in Adult Patients With Metastatic Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-11

Completion Date

2029-11

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

161Tb-PSMA-1 (radiopharmaceutical)

161Tb-PSMA-1 (from 7.4 GBq ± 10% to 11.5GBq ± 10%), intravenously (IV) for 4 cycles administered every 6 weeks. Dose Levels 161Tb-PSMA, IV, Q6W, 4 doses * DL-1 5.5 GBq ± 10% Q6W * DL1 (starting activity) 7.4 GBq ± 10% Q6W * DL2 9.5 GBq ± 10% Q6W * DL3 11.5 GBq ± 10% Q6W

Locations (1)

Centre Léon Bérard

Lyon, France