Spots Global Cancer Trial Database for Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901
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Trial Identification
Brief Title: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901
Official Title: An Open-Label, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CMG901 in Subjects With Advanced Unresectable or Metastatic Solid Tumor
Study ID: NCT04805307
Interventions
Study Description
Brief Summary: This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CMG901. The dose escalation part (Part A) will determine the MTD of CMG901 in subjects with relapsed and/or refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit, or the subject is not a candidate for such available therapy based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design). The dose expansion part (Part B) will evaluate the preliminary anti-tumor activity and safety of CMG901 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and pancreatic cancer who have relapsed and/or are refractory to approved therapies.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Affiliated Hospital of Hebei University, Baoding, , China
Hunan Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
Fujian Cancer Hosppital, Fuzhou, , China
Fujian Medical University Union Hospital, Fuzhou, , China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, , China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, , China
Hainan General Hospital, Haikou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The Second Hospital of Anhui Medical University, Hefei, , China
Affiliated Hospital of Jining Medical University, Jining, , China
Lanzhou University Second Hospital, Lanzhou, , China
The First Affiliated Hospital of Henan University of science and Technology, Luoyang, , China
Meizhou People's Hospital, Meizhou, , China
Jiangxi Cancer Hospital, Nanchang, , China
Huashan Hospital, Fudan University, Shanghai, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
The First Hospital of China Medical University, Shenyang, , China
The Forth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, , China
The Second Affiliated Hospital of Soochow University, Suzhou, , China
Hubei Cancer Hospital, Wuhan, , China
Tongji Hospital Tongji Medical College of HUST, Wuhan, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Contact Details
Name: Ruihua Xu
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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