MedTrace Logo

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

NCT05458544 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-04-29

No results posted yet for this study

Summary

Phase 1: The objective of the Phase 1 part of the clinical trial is to verify safety and tolerability (dose-limiting toxicity \[DLT\], maximum tolerated dose \[MTD\]) of a single 3.7 Giga-Becquerel (GBq) dose with the potential for one dose level de-escalation to 2.775 GBq if necessary, to determine the recommended \[177Lu\]Ludotadipep dose for use in the Phase 2a part of the trial.

Phase 2a: The objective of the Phase 2a part of the trial is to evaluate safety and efficacy for repeated administration of the recommended \[177Lu\]Ludotadipep dose. The Recommended Phase 2 dose (RP2D) will be based on the study results from the Phase 1 trial in South Korea upon consultation with the FDA.

Conditions

Interventions

DRUG

[177Lu]Ludotadipep 3.7 GBq

Phase 1: Patients will receive a single dose of 3.7 GBq of \[177Lu\]Ludotadipep * Test article code/name: \[177Lu\]Ludotadipep * Administration route: intravenous injection * Total dose strength: 3.7 GBq * Dosage form: solution for injection Phase 2a: Patients will receive 3.7 GBq of \[177Lu\]Ludotadipep every 8 \[±1\] weeks (4 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

  • Arif Hussain, MD · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-06-01
Completion
2025-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05458544 on ClinicalTrials.gov