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Clinical Trial · NCT06492122
Study With [225Ac]Ac-FL-020 in mCRPC Participants
Overview
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)
ClinicalTrials.gov
NCT06492122Drug / Compound
FL-020
Isotope(s):
ACTINIUM-225
Radioisotope: Ac-225
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 9.9 Days
Decay Mode: ALPHA, GAMMA
Energy: 5.8-8.4 MeV
Range: 47-85 micrometers
Decay Daughters: Ra225, Fr221, At217, Bi213, 209, Po213, 209, TL209, 205
Status: Clinical Trials Only
Target(s):
- PSMA
FL-020
Isotope(s):
INDIUM-111
Radioisotope: In-111
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 2.8 Days
Decay Mode: ELECTRON CAPTURE, GAMMA
Energy: 173 keV, 247 keV
Range: N/A
Decay Daughters: Cd111 (Stable)
Status: FDA Approvals: ONCOSCINT® (1992), OCTREOSCAN® (1994)
Target(s):
- PSMA
Eligibility
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.
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