RecruitingPhase 1Phase 2NCT04930432

Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

A Phase I/II Study of MCLA-129, a Human Anti-EGFR and Anti-c-Met Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors, Evaluating Safety, Pharmacokinetic Characteristics and Antitumor Activity

Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

400 participants

Start Date

Sep 24, 2021

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new antibody drug called MCLA-129 that targets two proteins (EGFR and cMet) on cancer cells in patients with advanced lung cancer or other solid tumors that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have advanced non-small cell lung cancer, or another solid tumor (such as head and neck cancer or colorectal cancer) - Your tumor has tested positive for EGFR or MET abnormalities - Your cancer has progressed after standard treatment, or you cannot tolerate standard treatment **You may NOT be eligible if...** - Your tumor does not have EGFR or MET abnormalities - You have not yet tried standard available treatments (unless you cannot tolerate them) - You are pregnant or breastfeeding - You have certain other serious health conditions 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

DRUGMCLA-129

MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.

Locations(87)

Affiliated Hospital of Hebei University

Baoding, China

Beijing Cancer Hospital

Beijing, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Beijing Tongren Hospital

Beijing, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University International Hospital

Beijing, China

The Fifth Medical Center of PLA Ceneral Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Cangzhou Hospital of Integrated TCM-WM·Hebei

Cangzhou, China

Ji Lin Cancer Hospital

Changchun, China

Hunan Cancer Hospital

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital of Central South University

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital, Sichuan University

Chengdu, China

Chifeng Municipal Hospital

Chifeng, China

Army Medical Center of PLA

Chongqing, China

Chongqing University Cancer Hospital

Chongqing, China

China-Japan Union Hospitai Of Jilin University

Ch’ang-ch’un, China

The First Affiliated Hospital of Dalian Medical University

Dalian, China

Fujian Cancer Hospital

Fuzhou, China

Fuzhou Pulmonary Hospital of Fujian

Fuzhou, China

The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

Fuzhou, China

First Affiliated Hospital Of Gannan Medical University

Ganzhou, China

Guangdong Province Traditional Chinese Medical Hospital

Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

The Frist Affiliated Hospital of Guangzhou Medical College

Guangzhou, China

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Hanzhong Central Hospital

Hanzhong, China

Harbin Medical University Cancer Hospital

Harbin, China

Cancer Hospital affiliated to Harbin Medical University

Ha’erbin, China

Harbin Medical University cancer hospital

Ha’erbin, China

The Second Hospital of Anhui Medical University

Hefei, China

Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

Henan, China

Inner Mongolia People's Hospital

Hohhot, China

Jiangxi cancer hospital

Jiangxi, China

The First Hospital of Jilin University

Jilin, China

Shandong Cancer Hospital & institute

Jinan, China

Yunnan Cancer Hospital

Kunming, China

The First Hospital of Lanzhou University

Lanzhou, China

Jiangxi Cancer Hospital

Nanchang, China

General Hospital of Eastern Theater Command

Nanjing, China

Jiangsu Cancer Hospital

Nanjing, China

Jiangsu Province Hospital

Nanjing, China

Nanjing Drum Tower Hospital

Nanjing, China

Guangxi Medical University Cancer Center

Nanning, China

Nantong Tumor Hospital

Nantong, China

Qingdao Central Hospital

Qingdao, China

The Affiliated Hospital of Qingdao University

Qingdao, China

First Hospital of Qinhuangdao

Qinhuangdao, China

ShangHai Chest Hospital

Shanghai, China

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Liaoning Cancer Hospital & Institute

Shenyang, China

Liaoning Cancer Hospital

Shenyang, China

The First Hospital of China Medical University

Shenyang, China

Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital

Shenzhen, China

Shenzhen People's Hospital

Shenzhen, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

General Hospital of Tianjin Medical University

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Tonghua Central Hospital

Tonghua, China

Weifang People's Hospital

Weifang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Hubei Cancer Hospital

Wuhan, China

Renmin Hospital of Wuhan University/Hubei General Hospital

Wuhan, China

Union Hospital, Tongji Medical College Huazhong University of Science and Technolog

Wuhan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Zhongnan Hospital Affiliated to Wuhan University

Wuhan, China

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)

Wuhu, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital Of Xiamen University

Xiamen, China

Xuzhou Central Hospital

Xuzhou, China

Yantai Yuhuangding Hospital

Yantai, China

The No. 2 People's Hospital of Yibin Sichuan

Yibin, China

Hospital of Ningxia Medical University

Yinchuan, China

He Nan Cancer Hospital

Zhengzhou, China

Henan Provincial People's Hospital

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Henan Provincial People's Hospital

Zhenzhou, China

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