NCT07407803 Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 177 participants in total. It began in 2026-03-31 with a primary completion date of 2027-12.

Brief 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 Criteria

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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