Spots Global Cancer Trial Database for To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors
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Trial Identification
Brief Title: To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors
Official Title: A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients With Advanced Recurrent or Metastatic Digestive System Tumors
Study ID: NCT05260385
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
Detailed Description: This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen. The study will consist of two parts: Part 1: QD regimen To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen. Part 2: BID regimen Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors. Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, , China
The first affiliated hospital of bengbu medical college, Bengbu, , China
Chongqing University Three Gorges Hospital, Chongqing, , China
Fujian Cancer Hospital, Fujian, , China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Henan, , China
The First Affiliated Hospital of Xinxiang Medical University, Henan, , China
Hubei Cancer Hospital, Hubei, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technologe, Hubei, , China
Shandong Cancer Hospital & Institute, Shandong, , China
Shanghai Chest Hospital, Shanghai, , China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center, Shenzhen, , China
Tianjin Medical University Cancer Institute &Hospital, Tianjin, , China
The Second Affiliated Hospital Zhejiang University School of Medicine, Zhejiang, , China
Contact Details
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