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RECRUITING
NCT05024214
PHASE1/PHASE2

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

Sponsor: 3D Medicines (Sichuan) Co., Ltd.

View on ClinicalTrials.gov

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

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.

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