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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.
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
Conditions
Interventions
Lu-177-DGUL
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
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