Full-Life Technologies UK Limited
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.
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic CRPC. 2. Age ≥ 18 years. 3. Signed informed consent, and able and willing to comply with protocol requirements prior to any study procedures. 4. Patients must have a life expectancy \>3 months. 5. All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan 6. Documented progression of the disease based on the Investigator judgement 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 8. Have a castrate serum testosterone \< 50 ng/dL or \<1.7 nmol/L. Patients must cont…
\[225Ac\]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
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.