A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients Wit
The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds.
| Condition(s) | Neurofibromatosis Type 1 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds. |
| Who can participate | Inclusion Criteria: 1. All participants must have a diagnosis of NF1 based on the 2021 revised consensus criteria. 2. Participants must have PN(s) that are progressive OR are causing significant morbidity, such as (but not limited to) head and neck lesions that are compromising the airway or great vessels, brachial or lumbar plexus lesions that are causing nerve compression and loss of function, lesions causing significant disfigurement (e.g., orbital lesions), lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions. Participants with paraspinal PN will be eligible for this trial. Histologic confirmation of tumor is not necessary but should be considered if there are clinical or radiographic findings concerning for malignant transformation of a PN. 3. |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | Healx Limited |
| Locations | Birmingham, Alabama, United States; Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States (+8 more sites) |
| Start date | 2025-02-10 |
| NCT ID | NCT06541847 |
| Official listing | https://clinicaltrials.gov/study/NCT06541847 |