Spots Global Cancer Trial Database for A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
Official Title: A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors
Study ID: NCT04495296
Conditions
Study Description
Brief Summary: This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and biliary tract cancer, etc.
Detailed Description: There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion study, and Part II is dose escalation and dose expansion study of combination therapy. The dose escalation study will be conducted utilizing 3+3 design with two dosing regimens, i.e. "once every 2 weeks (Q2W)" and "once every 3 weeks (Q3W)". After MTD/RP2D determined, three cohorts may be included in the expansion plan, with about 30 (20-40) subjects with positive CLDN18.2 expression be treated in each cohort, as shown below (during the study, the treatment cohorts may be adjusted or added based on the clinical and pre-clinical study data). Approximately 320-540 treated subjects in total
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University International Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi, Guangxi, China
Hainan Provincial People's Hospital, Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Heibei, China
Harbin Medical University Cancer Hospital, Ha'erbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Xiangya Hospital, Central South University, Changsha, Hunan, China
Suzhou Municipal Hospital, Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Chang chun, Jilin, China
The First Hospital of Jilin University, Chang chun, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Jinan Central Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Fudan University Shanghai Cance Center, Shanghai, Shanghai, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chendu, Sichuan, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
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