Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Neurofibromatosis Type 1 (NF1) based on the 2021 updated diagnosis guidelines.
• People who have one or more plexiform neurofibromas (a type of nerve tumour linked to NF1) that are either growing over time, or causing serious problems such as airway blockage, nerve damage, significant changes in appearance, limb swelling or loss of function, or pain.
• People whose tumour(s) can be measured using a specific type of MRI scan, where the tumour appears across at least 3 scan images and is at least 3 mL in size (roughly 3 cm across) — though smaller tumours may still be considered (confirm with trial site).
• People aged 12 years or older at the time of joining the trial.
• People who weigh at least 42 kg.
• People who are well enough to carry out at least half of normal daily activities, as measured by a standard health scoring tool used by the trial team.
• People whose bone marrow, kidneys, liver, and pancreas are functioning adequately, and whose blood pressure is within a normal range (blood pressure medicines are allowed if the dose has been stable for at least 14 days before joining).
• People who are able and willing to use effective contraception during the trial and for 4 months after the last dose — this applies to women who could become pregnant and to men who could father a child. Barrier methods alone (such as condoms) are not considered sufficient on their own. True abstinence or surgical sterility are acceptable alternatives.
• People who are not planning to have surgery or other treatments on the target tumour during the trial period.
• People (or their legal guardian) who are able to understand and voluntarily sign the informed consent form explaining the study risks.
• People who are willing and able to attend study visits and follow all study procedures, in the opinion of the trial doctor.

Who may not be able to join:

• People who have previously been treated with the study drug HLX-1502 for a plexiform neurofibroma.
• People who have recently used certain other medicines including MEK inhibitors, other targeted cancer drugs (TKIs), chemotherapy, biological cancer treatments, experimental drugs, or radiation therapy — specific waiting periods apply depending on the treatment (confirm with trial site).
• People who have another NF1-related tumour such as a brain tumour (including optic pathway glioma or high-grade glioma), a malignant nerve sheath tumour, or any other cancer currently needing treatment.
• People who have been treated for a high-grade brain tumour, malignant nerve sheath tumour, or other cancer in the past 12 months (some skin cancers that have been successfully treated may be exceptions — confirm with trial site).
• People who have dental braces or dental prostheses that would interfere with the MRI tumour measurements.
• People who have had major surgery within 12 weeks before starting the trial, or minor surgery within 1 month before the first dose, or who have not fully healed from a previous surgery.
• People who have cataracts identified during an eye examination.
• People who have significant heart or blood vessel conditions (confirm with trial site for specific details).
• People who have certain other serious health conditions that could make trial participation unsafe, including active infection, a known history of HIV, immune deficiency, or a known history of Hepatitis B or Hepatitis C.
• People who need to take certain other medications during the trial that are processed by specific liver enzymes (CYP1A2, CYP2C8, UGT1A1, UGT1A3) and have a narrow safe dosing range (confirm with trial site).
• People who have a known serious allergy or sensitivity to HLX-1502, any of its ingredients, or to similar types of compounds.
• People who have a known serious sensitivity to a yellow food dye called FD&C Yellow No. 5.
• People who are currently taking blood-thinning medicines known as vitamin K antagonists.
• People who currently have iron deficiency, are receiving iron replacement treatment, or need copper or zinc supplements at the time of joining the trial.
• Women who are pregnant or breastfeeding.
• People who are unable or unwilling to swallow tablets.
• People who have digestive system conditions that could significantly affect how the study drug is absorbed by the body.
• People who have other medical, personal, or social circumstances that may make it difficult to safely meet all trial requirements.

Important: Always verify eligibility with the trial site directly before applying.