Patients with Advanced Metastatic FAP-Positive Tumors
Conditions
Keywords
Lu-177, FAP, Tumor
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.
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
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 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 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response | through study completion, an average of 3 months | The number and size (long diameter in centimeter) of tumors were calculated and compared based on enhanced CT and MRI. The treatment effect of tumors was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactGuochang Wang, MD
Outcome results
None listed