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ACTIVE NOT RECRUITING
NCT05547061
PHASE1/PHASE2

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

Sponsor: Cellbion Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2021-04-12

Completion Date

2024-12-31

Last Updated

2024-12-11

Healthy Volunteers

Yes

Interventions

DRUG

Lu-177-DGUL

Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

DRUG

Ga-68-NGUL

Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.

Locations (4)

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea