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

Description:

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).

Sponsor:

Unknown Organization

Phase:

Phase 1

Contacts:

Full-Life Technologies (CONTACT)

clinicaltrials@t-full.com

+1 973-727-3254

Full-Life Technologies GmbH (STUDY_DIRECTOR)

FL-020

Isotope(s):
Target(s):
  • PSMA

FL-020

Isotope(s):
Target(s):
  • PSMA
Inclusion
  • Patients must have a life expectancy \>3 months.
  • All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan
  • 1. Histologically or cytologically confirmed metastatic CRPC.
Exclusion
  • More than 1 prior treatment with PSMA-targeted radioconjugate.
  • 1. Patients with known brain metastases.
  • Severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study.
  • Previous treatment with Actinium-225, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or hemi-body irradiation or any other radionuclide therapy except \[177Lu\]Lu-PSMA-617 and Radium-223.
  • Grade 3 Cystitis infective and non-infective.