NCT06492122

Study With [225Ac]Ac-FL-020 in mCRPC Participants

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of [225Ac]Ac-FL-020 in Participants With mCRPC.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Full-Life Technologies GmbH · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description

The aim of this Phase 1, First-in-Human, Open-label Trial is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of \[225Ac\]Ac-FL-020 as a single agent in participants with metastatic Castration-Resistant Prostate Cancer (mCRPC). \[111In\]In-FL-020 serves as a surrogate for 225Ac-FL-020 for dosimetry purposes. The trial is divided into two parts: dose escalation in Part 1 and cohort expansion in Part 2.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	[225Ac]Ac-FL-020	\[225Ac\]Ac-FL-020 injected intravenously
DRUG	Blood samples for PK	Following the first injection of \[225Ac\]Ac-FL-020, blood samples after treatment will be collected for PK evaluation.
DRUG	[111In]In-FL-020	A dose of \[111In\]In-FL-020 will be injected prior to the first dose of \[225Ac\]Ac-FL-020 for dosimetry evaluation
PROCEDURE	Blood and urine samples collection	For dosimetry evaluation and urine excretion assessment, blood and urine samples will be collected after the injection of \[111In\]In-FL-020
PROCEDURE	SPECT/CT images	For dosimetry evaluation, SPECT/CTs will be performed following the injection of \[111In\]In-FL-020.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-07-09
• Last updated: 2026-01-29

Locations

9 sites across 4 countries: United States, Australia, China, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study