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PSMA-directed Targeted Alpha Therapy With 225Ac-PSMA-I&T of Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.
Description:
The therapy is administered at 8 ± 1week intervals, with the initial activity of 100 kBq/kg (±10%), then de-escalation to 87 kBq/kg (±10%), 75 kBq/kg (±10%) or 50 kBq/kg (±10%) in cases of good response (PSA decline >50%). The route of administration will be Intravenous (I.V.) infusion over approximately 1-3 minutes.
Sponsor:
Fusion Pharmaceuticals, Inc.Contacts:
Clinical Trials Fusion Pharmaceuticals Inc.clinicaltrials@fusionpharma.com
1 (888) 506-4125
Government Study Link:
NCT05219500 - Click here to see study onClinicalTrials.gov
225Ac-PSMA-I&T
Isotope(s):
Target(s):
- PSMA
Ligand: Small Molecules
Chelator: DOTAGA
Inclusion
- Positive PSMA PET/CT scan
- Must have completed lutetium-PSMA therapy for more than 6 wks before first study drug dose
- Participants with known BRCA mutations should have received FDA approved therapies ie PARP inhibitors per PI discretio
- Phase 2 ECOG performance status 0 or 1
- Progressive mCRPC
Exclusion
- Previous treatment with any radiopharmaceutical
- Contraindications to or inability to perform the imaging procedures required in study
- Pt. with known CNS metastatic disease
- Radiation therapy within 28 days prior to the first dose of In FPI-2058
- Prior anti-cancer therapy (chemo, immuno, hormonal, targeted, investigational) within a specific time before In-FPI-2058
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
United States 🇺🇸
XCancer - Omaha
17607 Gold Plaza, Omaha, Nebraska 68130, United States
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States
Principal Investigator
Ebrahim Delpassand, MD
