NCT05963386

Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors

An Open-Label, Non-Randomized, Single-Center, Investigator-initiated Phase II Trial to Determine the Efficacy and Safety of 177Lu-DOTA-EB-FAPI in Patients With Various End-stage Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Increased fibroblast activation protein expression is positively correlated with the aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with refractory cancer and disease progression after multiple-lines treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to investigate the efficacy and safety of 177Lu-DOTA-EB-FAPI in patients with various solid tumors who had failed standard therapies.

Detailed description

This investigator-initiated phase II study will include a maximum of 30 subjects with progressive cancer after multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46 PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.3GBq (90 mCi) per cycle. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the radiological response (according to RECIST criteria) after completion of radioligand therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), dosimetry, and safety of 177Lu-DOTA-EB-FAPI.

Conditions

• Refractory Solid Tumor

Interventions

Type	Name	Description
DRUG	177Lu-DOTA-EB-FAPI radionuclide therapy	radionuclide therapy using 177Lu-DOTA-EB-FAPI 90 mCi (3.3 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.

Timeline

• Start date: 2022-02-22
• Primary completion: 2024-09-15
• Completion: 2024-10-05
• First posted: 2023-07-27
• Last updated: 2025-03-28

Locations

1 site across 1 country: China