177Lu-JH04 in Patients with FAP-Positive Tumors
- Conditions
- Patients with Advanced Metastatic FAP-Positive Tumors
- Interventions
- Drug: 3.70 GBq (100 mCi) of 177Lu-JH04Drug: 5.55 GBq (150 mCi) of 177Lu-JH04Drug: 7.40 GBq (200 mCi) of 177Lu-JH04
- Registration Number
- NCT06636617
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 3.70 GBq (100 mCi) of 177Lu-JH04 3.70 GBq (100 mCi) of 177Lu-JH04 All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04. 5.55 GBq (150 mCi) of 177Lu-JH04 5.55 GBq (150 mCi) of 177Lu-JH04 All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04. 7.40 GBq (200 mCi) of 177Lu-JH04 7.40 GBq (200 mCi) of 177Lu-JH04 All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04.
- Primary Outcome Measures
Name Time Method Toxic and side effect through study completion, an average of 2 weeks The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
- Secondary Outcome Measures
Name Time Method Dosimetry of normal organs and tumors through study completion, an average of 4 weeks The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-JH04. The dose delivered to normal organs and tumors will be recorded.
Trial Locations
- Locations (1)
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China