TheranosticTrials.org

Clinical Trial · NCT04509557

[177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer.

Overview

The study aims to evaluate the stability and efficacy after administration of \[177Lu\]Ludotadipep in patients with metastatic castration resistant prostate cancer (mCRPC), with dose-escalation applied to determine the appropriate dose.

Sponsor

FutureChem

Phase

Phase 1

Contacts

Ji Youl Lee (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04509557

Drug / Compound

PSMA

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

Ludotadipep

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

Eligibility

Inclusion

  • Patients who are positive on the \[18F\]PSMA PET/CT imaging

Exclusion

  • Subjects determined by an investigator to have a serious medical condition making study conduct difficult
  • Patients are excluded if treatment other than the treatment provided in this study is determined more appropriate as determined by the investigator based on the patient and disease characteristics
  • Subjects corresponding to the following conditions 1) Glomerular filtration rate ≤40 ml/min, 2) hemoglobin level ≤10.0 g/dL, 3) white cell count ≤4.0 × 109/L, 4) platelet count ≤100 × 109/L, 5) total bilirubin level ≥1.5 x upper normal limit, 6) serum albumin level ≤3.0 g/dL, 7) active ischemic heart disease or heart failure (New York Heart Association Classification III-IV), 8) uncontrolled diabetes/hypertension, 9) hyperkalemia \>6.0 mmol/L