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ACTIVE NOT RECRUITING
NCT07681141
PHASE1

Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies

Sponsor: First Affiliated Hospital of Fujian Medical University

View on ClinicalTrials.gov

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.

Official title: First-in-Human Safety and Dosimetry Study of ¹⁷⁷Lu-FAPI in Patients With FAP-Positive Malignancies

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2025-04-01

Completion Date

2027-12-31

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

DRUG

177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq

Subjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50 GBq.

Locations (1)

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

Fuzhou, Fujian, China