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)
IRC-Assessed Objective Response Rate (ORR) — From subject enrollment to the end of cycle 24 (each cycle is 28 days) Percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by independent review committee (IRC) per REiNS criteria at the end of Cycle 24.
Trial sites (29)
Facility
City
Region
Status
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
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.
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