FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas

Who can take part

• ≥ 18 years old and ≤ 70 years old
• Patients must be diagnosed with symptomatic NF1-related plexiform neurofibromas (PNs) and require systemic therapy at the investigator's discretion
• Presence of measurable lesions, defined as ≥ 3 cm in length in at least one dimension, which can be evaluated for efficacy by MRI
• Karnofsky performance status score ≥ 70
• Patients with adequate organ and bone marrow functions

Who cannot take part

• Patients with previous or current retinal vein obstruction (RVO), retinal pigment epithelial detachment (RPED), glaucoma, and other abnormal ophthalmic examination with clinical significance
• Interstitial pneumonia, including clinically significant radiation pneumonia
• NF1-related malignancies requiring chemotherapy, radiotherapy, or surgery, such as medium to high grade optic glioma or malignant peripheral nerve sheath tumor
• Patients with a history of or concurrently with other malignancies (excluding cured non-melanoma skin basal cell carcinoma, breast cancer in situ or cervical cancer in situ, and other malignancies without evidence of disease within 5 years)
• Cardiac function or combined diseases meet one of the following conditions:; QTcF value of > 470 milliseconds; patients with risk factors for QTcF prolongation or patients receiving drugs that prolong the QTcF interval; Congestive heart failure per New York Heart Association (NYHA) classification ≥ Class 3; Arrhythmias with clinical significance; Known concurrent clinically significant coronary artery disease, cardiomyopathy, and severe valvular disease; LVEF < 50%; Patients with a heart rate of < 50 beats/min
• Patients who cannot undergo MRI and/or have contraindications to MRI