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RECRUITING
NCT06492122
PHASE1

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

Sponsor: Full-Life Technologies GmbH

View on ClinicalTrials.gov

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).

Official title: 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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-08-30

Completion Date

2026-12

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

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.

Locations (9)

City of Hope Medical Center

Duarte, California, United States

Chao Family Comprehensive Cancer Center

Irvine, California, United States

University of Stanford

Stanford, California, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Princess Alexandra Hospital

Brisbane, Australia

Genesiscare Murdoch

Murdoch, Australia

MacQuarie University Clinical Trial Unit

Sydney, Australia

Beijing Cancer Hospital

Beijing, China

Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı

Ankara, Turkey (Türkiye)