NCT05740215

Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors

A Multicenter, Open-label, Phase Ib/II Study on the Efficacy and Safety of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors. About 138\~158 patients with advanced solid tumors plan to be enrolled in about 30 study sites of the study. Part I: Phase Ib study evaluating the safety and tolerability of F520 combined with lenvatinib in patients with advanced solid tumors. Part II: Phase II study of F520 combined with lenvatinib in endometrial cancer and cervical cancer.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	F520	F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2)
DRUG	Lenvatinib	Lenvatinib capsules

Timeline

• Start date: 2022-05-23
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2023-02-22
• Last updated: 2023-02-22

Locations

1 site across 1 country: China