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Brief Title: Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Official Title: A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Study ID: NCT05288205
Brief Summary: This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pecking Union Medical College Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy Of Medical Sciences, Beijing, Beijing, China
Beijing Tiantan Hospital, Captal Medical University, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Beijing Chest Hospital, Capital Medical University, Beijing, Beijing, China
Fujian cancer Hospital, Fuzhou, Fujian, China
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center, Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital-Mammary gland of internal, Ha'erbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Hust, Wuhan, Hubei, China
Renmin Hospital Of Wuhan University, Wuhan, Hubei, China
Xiangya Hospital Central South Univesity, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
The Second Hospital of Dalian Medical University, Dalian, Liaoning, China
The First Hospital Of China Medical University, Shenyang, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
The Affilated Hospital of Inner Mongolia Medical University, Hohhot, Neimenggu, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Shandong Cancer Hospital, Jinan, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'An Jiaotong University, Xi'an, Shanxi, China
West China Hospital Sichuan University, Chendu, Sichuan, China
Name: Jacobio Pharmaceuticals
Affiliation: Jacobio Pharmaceuticals
Role: STUDY_DIRECTOR