TheranosticTrials.org

Clinical Trial · NCT05557708

A Safety Study of 212Pb-Pentixather Radioligand Therapy

Overview

This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.

Sponsor

University of Iowa

Phase

Early Phase 1

Contacts

Yusuf Menda, MD (CONTACT)

yusuf-menda@uiowa.edu

319-356-3214

Kellie Bodeker, Ph.D. (CONTACT)

kellie-bodeker@uiowa.edu

319-384-9425

Yusuf Menda, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05557708

Drug / Compound

Pentixather

Isotope(s):
Target(s):
  • CXCR4
Ligand Class: Peptides
Chelator: DOTA
Linker: AMBS

Pentixather

Isotope(s):
Target(s):
  • CXCR4
Ligand Class: Peptides
Chelator: DOTA
Linker: AMBS

Eligibility

Inclusion

  • adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL; neutrophil count ≥ 1,500 cells/mm3)
  • adequate kidney function (creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation
  • failed initial therapy or declined further therapy known to confer benefit
  • have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT
  • ability to provide independent consent
  • adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)

Exclusion

  • refusal to comply with birth control requirements during study
  • allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent
  • antoher investigational agent within 4 weeks of consent
  • pregnancy
  • prior solid organ transplant
  • breastfeeding
  • antibody therapy within the 21 days of consent
  • uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness/social situations that would limit compliance with study requirements.
  • cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)
  • major surgery within 4 weeks of consent