NCT05579184

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

Phase 2 Study of Repeat-dose [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: FutureChem · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

100 mCi of \[177Lu\]Ludotadipep, the dose determined in the phase 1 clinical trial (FC705-1), was administered repeatedly up to 6 times at intervals of 8 weeks (±2 weeks) to patients with metastatic castration resistant prostate cancer (mCRPC) in order to assess the safety and efficacy.

Conditions

• Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

Type	Name	Description
DRUG	[177Lu]Ludotadipep	Patients will receive 100 mCi of \[177Lu\]Ludotadipep every 8 \[±1\] weeks (up to 6 times) * Test article code/name: \[177Lu\]Ludotadipep * Administration route: intravenous injection * Total dose strength: 4 to 6 x 3.7 GBq * Dosage form: solution for injection

Timeline

• Start date: 2022-10-30
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-13
• Last updated: 2024-04-29

Locations

1 site across 1 country: South Korea