Trials / Active Not Recruiting
Active Not RecruitingNCT05547061
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- Cellbion Co., Ltd. · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2022-09-21
- Last updated
- 2024-12-11
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05547061. Inclusion in this directory is not an endorsement.