RecruitingEarly Phase 1NCT06636617

177Lu-JH04 in Patients with FAP-Positive Tumors

Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

9 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria3

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

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Interventions

DRUG3.70 GBq (100 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.

DRUG5.55 GBq (150 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04

DRUG7.40 GBq (200 mCi) of 177Lu-JH04

All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04


Locations(1)

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

Fuzhou, Fujian, China

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NCT06636617