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NCT07681141
Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies
Conditions: Patients With Advanced Metastatic FAP-Positive Tumors
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 3
Sponsor: First Affiliated Hospital of Fujian Medical University
Location: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Summary
This first-in-human study aimed to assess the safety and internal radiation dosimetry of 177Lu-JH040182, a novel FAP-targeted radiopharmaceutical, in patients with FAP-positive tumors. All patients underwent screening via 68Ga-FAPI PET/CT. Those confirmed to have FAP-positive lesions on PET imaging received administration of 177Lu-JH040182, and serial-time-point SPECT images were acquired for internal radiation dosimetry calculations.
Eligibility Criteria
Inclusion Criteria:
* progressive advanced metastatic tumors
* tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
* 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
Source: ClinicalTrials.gov (NCT07681141). StuddyBuddy aggregates publicly available trial information.
