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

Exclusion Criteria24

• 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.