Spots Global Cancer Trial Database for Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection
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Trial Identification
Brief Title: Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8006 for Injection
Official Title: A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BAT8006 for Injection in Patients With Advanced Solid Tumors
Study ID: NCT05378737
Conditions
Interventions
Study Description
Brief Summary: Objectives: To evaluate the safety and tolerability of BAT8006 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
Detailed Description: In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8006 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Cancer Hospital, Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, Beijing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Sun Yat-Sen Memorlal Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute, Nanning, Guangxi, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Hust, Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
The First Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital&Institute, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Contact Details
Name: Yanhua Ding
Affiliation: The First Hospital of Jilin University
Role: PRINCIPAL_INVESTIGATOR
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