Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07407803
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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