drugset / Trial / NCT07587996

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

NCT07587996 ↗

Phase 0 Completed 12 enrolled Lanzhou University Second Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-20
Primary completion
2026-03-20
Completion
2026-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-CTR-FAPI Other / unclassified 3700 mbq Intravenous
Subject 177Lu-CTR-FAPI Other / unclassified 7400 mbq Intravenous