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

NCT05579184 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • FutureChem

    lead INDUSTRY

Principal Investigators

  • Ji Youl Lee, Ph.D · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579184 on ClinicalTrials.gov