Clinical Trial

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

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated December 11, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-09-15; most recent amendment 2024-12-09.
Status change: Recruiting → Active, Not Recruiting 2024-12-04
Trial Details
NCT Number NCT05547061
Lead Sponsor Cellbion Co., Ltd.
Conditions Prostate Cancer, mCRPC
Enrollment 91 participants
Start Date 2021-04-12
Primary Completion 2024-12-31 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-11