RecruitingPhase 1Phase 2NCT05458544

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

A Phase 1 Open-label, Dose-finding Multi-center Trial of [177Lu]Ludotadipep in Metastatic Castration-resistant Prostate Cancer Patients, Followed by an Open-label, Repeat Dose, Multi-center Phase 2a Trial to Assess Safety and Efficacy

Sponsor

FutureChem

Enrollment

26 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug called Ludotadipep (labeled with lutetium-177) in men with castration-resistant prostate cancer — meaning the cancer continues to grow even when testosterone levels are very low. The drug is designed to seek out a protein commonly found on prostate cancer cells and deliver radiation directly to them, sparing surrounding healthy tissue. **You may be eligible if...** - You are male and at least 18 years old - You have prostate cancer confirmed by biopsy that is no longer responding to hormone-lowering therapy - Your cancer does not have neuroendocrine or small cell features - Your organ function (kidneys, liver, blood counts) is adequate for treatment **You may NOT be eligible if...** - You have had certain prior radiation treatments to bone (e.g., radium-223) - You have serious kidney, liver, or bone marrow problems - You have uncontrolled other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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