TheranosticTrials.org

Clinical Trial · NCT07681141

Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies

Overview

This first-in-human study aimed to assess the safety and internal radiation dosimetry of 177Lu-JH040182, a novel FAP-targeted radiopharmaceutical, in patients with FAP-positive tumors. All patients underwent screening via 68Ga-FAPI PET/CT. Those confirmed to have FAP-positive lesions on PET imaging received administration of 177Lu-JH040182, and serial-time-point SPECT images were acquired for internal radiation dosimetry calculations.

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase 1

Contacts

Weibing Miao, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07681141

Drug / Compound

FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

JH040182

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

Eligibility

Inclusion

  • an Eastern Cooperative Oncology Group performance status of 0-2
  • tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
  • progressive advanced metastatic tumors

Exclusion

  • received other radionuclide therapy in the past 6 months
  • received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days