drugset / Trial / NCT05740215

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

NCT05740215

Phase 1/2 Unknown 158 enrolled Shandong New Time Pharmaceutical Co., LTD
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-23
Primary completion
2024-05-22
Completion
2024-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject F520 Monoclonal antibody 200 mg Intravenous
Subject Lenvatinib Small molecule 12 mg Oral
Subject Lenvatinib Small molecule 16 mg Oral
Subject Lenvatinib Small molecule 20 mg Oral

Indications