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Clinical Trials in China / NCT07407803
Recruiting Phase 3

Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas

NCT07407803 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 3
Started
2026-03-31
Last updated
2026-05-27

Condition(s) studied

Plexiform Neurofibroma

Investigational drug(s) / intervention(s)

TQ-B3234 capsulesTQ-B3234 placebo

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * The subject voluntarily joins this study, signs the informed consent form, and demonstrates good compliance. * Age ≥18 years (calculated from the date of signing the informed consent form). * Diagnosis of symptomatic, non-resectable neurofibromatosis type 1 (NF1)-associated plexiform neurofibroma (PN) requiring systemic therapy per investigator judgment. * At least one measurable lesion with a dimension ≥3 cm. * There should be no significant changes in the use of chronic neuropathic pain medications within 28 days prior to study enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Laboratory tests meet the protocol criteria. * Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion. A negative serum pregnancy test must be documented within 7 days prior to study enrollment. Men must agree to use effective contraception during the study and for 6 months after study completion. Exclusion Criteria: * Confirmed or suspected malignant glioma or malignant peripheral nerve sheath tumor (MPNST) (excluding low-grade glioma, optic nerve glioma not requiring systemic therapy or radiotherapy); histological confirmation may be required. * History of or concurrent other malignancies within 5 years prior to first dosing. * Multiple factors affecting oral drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction, major bowel resection). * Adverse reactions from prior anti-tumor therapy not recovered to NCI CTCAE v6.0 grade ≤1, except grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy. * Major surgery, significant traumatic injury, or planned major surgery during the study within 4 weeks prior to first dosing; or presence of long-term non-healed wounds or fractures. * History of arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack (TIA), deep vein thrombosis, pulmonary embolism) or other severe thromboembolic events within 6 months prior to first dosing. * Active viral hepatitis with poor control. * Active syphilis requiring treatment. * Active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia. * History of substance abuse that cannot be controlled or presence of psychiatric disorders. * Planned or prior allogeneic bone marrow or solid organ transplantation. * History of hepatic encephalopathy. * History of or current retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), central serous retinopathy (CSR), glaucoma, or other significant ocular abnormalities (e.g., intraocular pressure \>21mmHg). * Inability to undergo MRI and/or presence of MRI contraindications. * Major cardiovascular disease. * Active or uncontrolled severe infection. * Renal failure requiring hemodialysis or peritoneal dialysis. * History of immunodeficiency, including HIV-positive or other acquired/congenital immunodeficiency diseases. * History of epilepsy. * Tumor-related symptoms and treatment. * Known hypersensitivity to study drug excipients. * Participation in and use of other PN clinical trial drugs within 4 weeks prior to first dosing. * Pregnant or lactating participants. * Any other condition that, in the investigator's judgment, poses a serious risk to participant safety or interferes with study completion.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
Xuanwu Hospital Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Peking University Third Hospital Beijing Beijing Municipality Not Yet Recruiting
The Southwest Hospital of Amu Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Fujan Medical University Fuzhou Fujian Not Yet Recruiting
Gansu Provincial Cancer Hospital Lanzhou Gansu Not Yet Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
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 Not Yet Recruiting
Guangxi Medical University Cancer Hospital ( Guangxi Cancer InstituteGuangxi Cancer Hospital & Medical University Oncology School & Cancer Center) Nanning Guangxi Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Not Yet Recruiting
The second hospital of Hebei medical university Shijiazhuang Hebei Not Yet Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Not Yet Recruiting
The First Affiliated Hospital Of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Renmin Hospital of Wuhan University(Hubei General Hospital) Wuhan Hubei Not Yet Recruiting
Hunan Children's Hospital Changsha Hunan Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting
The First Affiliated Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
Xijing hospital Xi'an Shaanxi Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanxi Cancer Hospital Taiyuan Shanxi Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital Chengdu Sichuan Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Not Yet Recruiting
The First Affiliated Hospital Of Kunming Medical University Kunming Yunnan Not Yet Recruiting
Zhejiang Provincial People'S Hospital Hangzhou Zhejiang Not Yet Recruiting

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07407803 on ClinicalTrials.gov ↗ ← All trials in China