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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
\[225Ac\]Ac-FL-020 injected intravenously
Following the first injection of \[225Ac\]Ac-FL-020, blood samples after treatment will be collected for PK evaluation.
A dose of \[111In\]In-FL-020 will be injected prior to the first dose of \[225Ac\]Ac-FL-020 for dosimetry evaluation
City of Hope Medical Center
Duarte, California, United States
RECRUITINGChao Family Comprehensive Cancer Center
Irvine, California, United States
RECRUITINGDose escalation: Incidence of Dose-Limiting Toxicities (DLTs).
RP2D
Time frame: 28 days after the first injection of [225Ac]Ac-FL-020
Dose escalation and dose expansion: Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: From ICF signature and up to 42 days after the last dose of study treatment for all AE and SAE. Then only the AE/SAE suspected to be related to the study treatment will be reported.
Dose escalation and dose expansion: Absorbed doses
Absorbed doses in different organs and tumors
Time frame: During one week following the injection of [111In]In-FL-020
Peak Plasma Concentration (Cmax)
Pharmacokinetics
Time frame: During one week following the first injection of [225Ac]Ac-FL-020
Area Under the Plasma concentration versus time curve
Pharmacokinetics
Time frame: During one week following the first injection of [225Ac]Ac-FL-020
Overall response rate
Anti-tumor activity via imaging assessments and PSA levels
Time frame: 2 years
Disease Control Rate
Anti-tumor activity via imaging assessments and PSA levels
Time frame: 2 years
Best Overall response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For dosimetry evaluation and urine excretion assessment, blood and urine samples will be collected after the injection of \[111In\]In-FL-020
For dosimetry evaluation, SPECT/CTs will be performed following the injection of \[111In\]In-FL-020.
University of Stanford
Stanford, California, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
RECRUITINGPrincess Alexandra Hospital
Brisbane, Australia
RECRUITINGGenesiscare Murdoch
Murdoch, Australia
RECRUITINGMacQuarie University Clinical Trial Unit
Sydney, Australia
RECRUITINGBeijing Cancer Hospital
Beijing, China
RECRUITINGAnkara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı
Ankara, Turkey (Türkiye)
RECRUITINGAnti-tumor activity via imaging assessments and PSA levels
Time frame: 2 years
Progression Free Survival
Anti-tumor activity via imaging assessments and PSA levels
Time frame: 2 years
Overall Survival
Anti-tumor activity
Time frame: 2 years