RecruitingPhase 2NCT06541847

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


Sponsor

Healx Limited

Enrollment

25 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HLX-1502 for people with neurofibromatosis type 1. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX-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).


Locations(14)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York University Langone Health

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06541847


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