RecruitingPhase 1NCT06492122

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.

Sponsor

Full-Life Technologies GmbH

Enrollment

50 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted radioactive therapy called [225Ac]Ac-FL-020 in men with metastatic castration-resistant prostate cancer (mCRPC) — meaning prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. The drug seeks out prostate cancer cells by targeting a protein called PSMA and delivers radiation directly to the tumor. **You may be eligible if...** - You are 18 or older with confirmed metastatic castration-resistant prostate cancer - Your cancer cells show PSMA (a specific protein) on a special PET/CT scan - Your testosterone levels are very low (castrate levels) - Your expected survival is more than 3 months and you are in reasonably good health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer does not show PSMA on a PET scan - You have significant kidney, liver, or bone marrow problems - You have had recent radiation therapy to a large area of the skeleton - You are unable to comply with radiation safety precautions 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[225Ac]Ac-FL-020

\[225Ac\]Ac-FL-020 injected intravenously

DRUGBlood 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

PROCEDUREBlood 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

PROCEDURESPECT/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)

View Full Details on ClinicalTrials.gov

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NCT06492122

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