NCT06375564

Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.

Detailed description

Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.

Conditions

• Refractory Solid Tumor

Interventions

Type	Name	Description
DRUG	177Lu-AB-3PRGD2 radioligand therapy	Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2024-04-19
• Last updated: 2025-08-08

Locations

1 site across 1 country: China