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Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
Sponsor: Lanzhou University Second Hospital
Summary
This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer. The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy. The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.
Official title: An Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-11-20
Completion Date
2026-04-20
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI
a novel covalent targeted radioligand (CTR), ¹⁷⁷Lu-CTR-FAPI, utilizing a sulfur(VI) fluoride exchange (SuFEx) click chemistry-based strategy
Locations (1)
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China