Clinical trial · Interventional
Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQ-B3234 Capsules Versus Placebo in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plexiform Neurofibroma | Plexiform Neurofibroma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3234 capsules | Drug | — | UNRESOLVED |
| TQ-B3234 placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TQ-B3234 capsules
- description
- TQ-B3234 capsules: 50 mg once daily, one cycle every 4 weeks (28 days)
- interventionNames
- Drug: TQ-B3234 capsules
- type
- PLACEBO_COMPARATOR
- label
- TQ-B3234 placebo
- description
- TQ-B3234 placebo: 0 mg once daily, one cycle every 4 weeks (28 days)
- interventionNames
- Drug: TQ-B3234 placebo
Primary outcomes (1)
- measure
- IRC-Assessed Objective Response Rate (ORR)
- timeFrame
- From subject enrollment to the end of cycle 24 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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