177Lu-JH04 in Patients with FAP-Positive Tumors
Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
First Affiliated Hospital of Fujian Medical University
9 participants
Aug 21, 2024
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
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
All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.
All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04
All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06636617