drugset / Trial / NCT07244393

Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer

NCT07244393 ↗

Phase 1 Not yet recruiting 30 enrolled Cellbion Co., Ltd. Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy. Participants will: Monotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals Combination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals

Timeline

Start
2025-12
Primary completion
2029-04
Completion
2029-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lutetium (177Lu) DGUL Unknown — —
Subject Pembrolizumab Monoclonal antibody 400 mg —

Indications