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A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1

NCT06541847 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-19

No results posted yet for this study

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

  • Neurofibromatosis Type 1

Interventions

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).

Sponsors & Collaborators

  • Healx Limited

    lead INDUSTRY

Principal Investigators

  • Miriam Bornhorst · Lurie's Children's Hospital

  • Michael Fisher · Children's Hospital of Philadelphia

  • Kathryn Nevel · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2027-06-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541847 on ClinicalTrials.gov