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Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
Sponsor: 3D Medicines (Sichuan) Co., Ltd.
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.
Official title: Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2021-11-15
Completion Date
2026-12
Last Updated
2026-03-25
Healthy Volunteers
No
Interventions
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.
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.
Locations (23)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Seventh Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhongshan Hospital,Fudan University(Xiamen Branch)
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliater Hospital of Nanchang University
Nanchang, Jiangxi, China
THE First Hospital of Jilin University
Changchun, Jilin, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Cancer Affiliated Hospital of Xinjiang Medical College
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Fudan University
Shanghai, China