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Brief Title: EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Official Title: Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Study ID: NCT05176665
Brief Summary: This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.
Detailed Description: This is an open-label, Phase Ib/II, multi-stage study of EMB-01 in patients with advanced gastrointestinal tumors including gastric cancer, hepatocellular cancer, cholangiocarcinoma cancer and colorectal cancer, who have EGFR/cMET gene alterations or protein over expression and progressed on available standard therapies and for whom no standard therapy exists that would confer clinical benefit. All patients will be prescreened for cMET and EGFR genetic alterations and protein expression. Only those who met the molecular pre-screening criteria will proceed to clinical screening to determine the eligibility. The study will consist of Phase Ib part and Phase II part, both phases will consist of a molecular prescreening period, screening period, treatment period, safety follow-up period, and disease progression follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
MD Anderson Cancer Center, Houston, Texas, United States
Beijing cancer Hospital, Beijing, Beijing, China
Nanfang Hospital, Guangzhou, Guangdong, China
Hunan Cancer Hospital, Changsha, , China
West China Hospital, Sichuan University, Chengdu, , China
The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
Gansu Provincial Hospital, Lanzhou, , China
The Affiliated hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China