drugset / Trial / NCT05547061

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy

NCT05547061 ↗

Phase 1/2 Active not recruiting 91 enrolled Cellbion Co., Ltd.
Non-randomizedFactorialOpen-labelTreatment

Summary

This clinical trial is an open-label, single-arm, multi-center, escalation (Phase 1 Part B only), rater-blind (Phase 2 only), phase 1/2 trial to evaluate the diagnostic validity/safety of Ga-68-NGUL and efficacy/safety of Lu-177-DGUL on the anti-tumor activity that aims to simultaneously evaluate diagnostic and therapeutic validity.

Timeline

Start
2021-04-12
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ga-68-NGUL Diagnostic / imaging agent 2 mbq/kg Intravenous
Subject Lu-177-DGUL Unknown 5550 mbq Intravenous
Subject Lu-177-DGUL Unknown 7400 mbq Intravenous