[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
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.