177Lu-JH04 in Patients with FAP-Positive Tumors

Last updated: October 9, 2024
Sponsor: First Affiliated Hospital of Fujian Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

3.70 GBq (100 mCi) of 177Lu-JH04

7.40 GBq (200 mCi) of 177Lu-JH04

5.55 GBq (150 mCi) of 177Lu-JH04

Clinical Study ID

NCT06636617
FirstAHFujian-177Lu-JH04
  • Ages 18-80
  • All Genders

Study Summary

This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • progressive advanced metastatic tumors

  • tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT

  • adequate renal, haematological, and liver function

  • an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion

Exclusion Criteria:

  • pregnant or lactating women

  • received other radionuclide therapy in the past 6 months

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

Study Design

Total Participants: 9
Treatment Group(s): 3
Primary Treatment: 3.70 GBq (100 mCi) of 177Lu-JH04
Phase: 1
Study Start date:
August 21, 2024
Estimated Completion Date:
August 31, 2025

Study Description

Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.

Connect with a study center

  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

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