Phase I/II Study Evaluating PSMA Targeted Radionuclide Therapy in Adult Patients With Metastatic Clear Cell Renal Cancer
Status:
Recruiting
Trial end date:
2027-04-01
Target enrollment:
Participant gender:
Summary
This study is an open label Phase I/II study conducted according to a Fleming design,
investigating the safety and the efficacy of 4 IV injections of 177Lu-PSMA-1 in patients with
metastatic clear cell renal cancer.
This trial is divided in 2 parts:
- A safety run-in part aiming to assess the safety of 177Lu-PSMA-1 (with 6 patients
treated at the starting activity = 7.4 GBq of 177Lu-PSMA-1, every 6 weeks (Q6W) for 4
administrations). If more than one patient experiences a ST during the first cycle of
therapy (6 weeks), then a lower activity of 177Lu-PSMA-1 will be evaluated in an
additional cohort of 6 patients (5.9 GBq). The 6 patients from this safety run-in step,
treated at the activity selected for phase II, will be included in the evaluation of
Phase II part.
- A Phase II part aiming to assess the clinical activity of 177Lu-PSMA-1