Trials / Recruiting
RecruitingNCT06541847
A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1
A Phase 2, Open-Label, Single Arm, Non-Controlled, Single-Stage Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Plexiform Neurofibroma and Neurofibromatosis Type 1
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Healx Limited · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX-1502 | Participants will take an oral dose three times a day (with or without food) for up to 24 cycles (a cycle is defined as 28 days). |
Timeline
- Start date
- 2025-02-10
- Primary completion
- 2027-06-01
- Completion
- 2028-01-01
- First posted
- 2024-08-07
- Last updated
- 2026-03-20
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06541847. Inclusion in this directory is not an endorsement.