NCT05024214

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: 3D Medicines (Sichuan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center study of Phase Ib/II study to assess the efficacy and safety of Envafolimab combinded with Lenvatinib in the treatment of subjects with advanced solid tumors. The primary hypothesis of this study is that subjects will have a better objective response rate (ORR) when treated with Envafolimab plus Lenvatinib than SOC.

Conditions

• Solid Tumors
• Non-small Cell Lung Cancer
• Renal Cell Carcinoma
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Lenvatinib + Envafolimab	Lenvatinib will be administered with water orally once a day (with or without food) continuously in 28-day treatment cycle. Envafolimab, 400 mg per dose, subcutaneous injection, dosed on D1 and then D15 of Treatment Cycle 1, and D1 of Treatment Cycle 2 and every subsequent cycles, with every 28 days as one treatment cycle.
DRUG	Sunitinib	Sunitinib will be administered with water orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) in 42-day treatment cycle.

Timeline

• Start date: 2021-11-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-08-27
• Last updated: 2026-03-25

Locations

23 sites across 1 country: China