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New treatment option for Plexiform Neurofibroma
Official title Evaluation of TQ-B3234 Capsules in Patients With Symptomatic, Non-Surgical Type 1 Neurofibromatosis-Associated Plexiform Neurofibromas
ClinicalTrials.gov ID: NCT07407803
What this study is testing
What is TQ-B3234 capsules?
TQ-B3234 capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for plexiform neurofibroma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Confirmed or suspected malignant glioma or malignant peripheral nerve sheath tumor (MPNST) (excluding low-grade glioma, optic nerve glioma not...
- 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...
- Major surgery, significant traumatic injury, or planned major surgery during the study within 4 weeks prior to first dosing; or presence of long-term...
- History of arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack (TIA), deep vein thrombosis...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.