New pill could shrink nerve tumors in NF1 patients
NCT ID NCT07407803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new drug called TQ-B3234 can shrink non-surgical nerve tumors (plexiform neurofibromas) in adults with neurofibromatosis type 1 (NF1). About 177 participants will receive either the drug or a placebo. The main goal is to see if the drug reduces tumor size after 24 weeks. This is a phase 3 trial, meaning it is in the final stage before possible approval.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 177 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
29 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100070, China
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Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital / Guangdong Center for the Prevention and Control of Sexually Transmitted Diseases and Leprosy
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510091, China
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Gansu Provincial Cancer Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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Guangxi Medical University Cancer Hospital （ Guangxi Cancer InstituteGuangxi Cancer Hospital & Medical University Oncology School & Cancer Center）
NOT_YET_RECRUITINGNanning, Guangxi, 530021, China
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Guizhou Provincial People's Hospital
NOT_YET_RECRUITINGGuiyang, Guizhou, 550002, China
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Hunan Children's Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410007, China
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Nanjing Drum Tower Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210008, China
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Peking Union Medical College Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100032, China
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100083, China
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Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, 250012, China
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Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, 250012, China
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Renmin Hospital of Wuhan University(Hubei General Hospital)
NOT_YET_RECRUITINGWuhan, Hubei, 42000, China
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Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200011, China
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Shanxi Cancer Hospital
RECRUITINGTaiyuan, Shanxi, 030000, China
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Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610072, China
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Sun Yat-Sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510060, China
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The First Affiliated Hospital Of Kunming Medical University
NOT_YET_RECRUITINGKunming, Yunnan, 650000, China
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The First Affiliated Hospital Of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITINGHefei, Anhui, 230000, China
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The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110801, China
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The First Affiliated Hospital of Fujan Medical University
NOT_YET_RECRUITINGFuzhou, Fujian, 350004, China
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The Second Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471000, China
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The Southwest Hospital of Amu
RECRUITINGChongqing, Chongqing Municipality, 400000, China
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The second hospital of Hebei medical university
NOT_YET_RECRUITINGShijiazhuang, Hebei, 05000, China
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Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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Xijing hospital
NOT_YET_RECRUITINGXi'an, Shaanxi, 710000, China
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Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100032, China
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Zhejiang Provincial People'S Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World study tracks Selumetinib's impact on NF1 tumors in children
- Could a cancer drug shrink Children's brain tumors?
- New drug shows promise for shrinking painful NF1 tumors
- New study tracks Long-Term safety of NF1 drug in kids
- New hope for kids with resistant tumors: drug combo enters safety trial
- Blood test could spot rare nerve tumors years earlier in NF1 patients