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COMPLETED
NCT07587996
EARLY_PHASE1

Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors

Sponsor: Lanzhou University Second Hospital

View on ClinicalTrials.gov

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

DRUG

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