RecruitingPhase 1Phase 2NCT05024214

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

Sponsor

3D Medicines (Sichuan) Co., Ltd.

Enrollment

170 participants

Start Date

Nov 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of envafolimab (an immunotherapy given as an injection under the skin) and lenvatinib (a targeted drug) for people with advanced solid tumors — including lung cancer, kidney cancer, and liver cancer — whose cancer has stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor - In Phase Ib: Your cancer has progressed after standard treatment, or no effective treatment exists - In Phase II: You have advanced lung cancer (NSCLC), kidney cancer (RCC), or liver cancer (HCC) that progressed after prior PD-(L)1 immunotherapy, with 2 or fewer prior treatment lines - You have accessible tumor tissue for testing - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have active autoimmune disease or are on immunosuppressants - You have uncontrolled high blood pressure or significant heart problems - You are pregnant or breastfeeding - You have active or recent serious bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib + 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.

DRUGSunitinib

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

View Full Details on ClinicalTrials.gov

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