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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |