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Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Summary
This study aims to demonstrate that in subjects with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, TQ-B3234 capsules significantly improve the objective response rate at Week 24 compared to placebo.
Official title: Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2026-03-31
Completion Date
2028-12
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
TQ-B3234 capsules
TQ-B3234 is an antitumor molecular targeted drug, a selective mitogen-activated protein kinase 1 and 2 (MEK1/2) inhibitor. It primarily inhibits the mitogen-activated protein kinase (MEK) protein (an upstream regulator of the extracellular signal-regulated kinase (ERK) pathway), thereby affecting the mitogen-activated protein kinase (MAPK) pathway and suppressing cell proliferation. MEK inhibitors are recognized to play a significant role in the pathogenesis of plexiform neurofibromas associated with neurofibromatosis type 1.
TQ-B3234 placebo
TQ-B3234 placebo without drug substance.
Locations (29)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujan Medical University
Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital / Guangdong Center for the Prevention and Control of Sexually Transmitted Diseases and Leprosy
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital ( Guangxi Cancer InstituteGuangxi Cancer Hospital & Medical University Oncology School & Cancer Center)
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The second hospital of Hebei medical university
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University(Hubei General Hospital)
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Xijing hospital
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, China