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.
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.
Arms & 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.
Outcome measures
Primary
Dose 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.
Secondary
Dose escalation and dose expansion: Absorbed doses
Time frame: During one week following the injection of [111In]In-FL-020
Peak Plasma Concentration (Cmax)
Time frame: During one week following the first injection of [225Ac]Ac-FL-020
Area Under the Plasma concentration versus time curve
Time frame: During one week following the first injection of [225Ac]Ac-FL-020
Overall response rate
Time frame: 2 years
Disease Control Rate
Time frame: 2 years
Best Overall response
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Eligibility criteria
Study locations (5)
City of Hope Medical Center
Duarte, California, 91010
Chao Family Comprehensive Cancer Center
Irvine, California, 92612
University of Stanford
Stanford, California, 94305
University Hospital of Cleveland
Cleveland, Ohio, 44106
University of Virginia Cancer Center
Charlottesville, Virginia, 22903