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NCT05458544 · ClinicalTrials.gov registry record · Phase 1
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by FutureChem.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 4
- Study locations
NCT05458544 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by FutureChem. The registered enrollment target is 26 participants, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT05458544, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by FutureChem.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 4
- Study locations
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 Studied
Interventions
- DRUG [177Lu]Ludotadipep 3.7 GBq
Study Locations (4)
Maryland
- University of Maryland - Baltimore
- Chesapeake Urology Research Associates - Towson
California
- VA Greater Los Angeles Healthcare System,Cancer Center Research - Los Angeles
Pennsylvania
- Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) - Gettysburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05458544
The ClinicalTrials.gov registry entry for NCT05458544 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (87% lower). The listed sponsor is FutureChem, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which [177Lu]Ludotadipep 3.7 GBq is the first listed.
NCT05458544 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Maryland, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05458544 about?
NCT05458544 is a clinical study titled "[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application". 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...
What is the current status of trial NCT05458544?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2022-09-01. Estimated completion is 2025-06-01.
What conditions does trial NCT05458544 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT05458544?
The interventions under investigation include: [177Lu]Ludotadipep 3.7 GBq (DRUG).
Who is sponsoring clinical trial NCT05458544?
This trial is sponsored by FutureChem, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05458544 being conducted?
This trial has 4 study locations across California, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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