TheranosticTrials.org
Fusion Pharmaceuticals, Inc.

Clinical Trial · NCT05219500

PSMA-directed Targeted Alpha Therapy With 225Ac-PSMA-I&T of Castration-resISTant Prostate Cancer (TATCIST). A Phase II Clinical Trial.

Overview

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.

Phase

Phase 2

Contacts

Clinical Trials Fusion Pharmaceuticals Inc.

clinicaltrials@fusionpharma.com

1 (888) 506-4125

ClinicalTrials.gov

NCT05219500

Drug / Compound

225Ac-PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

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.

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