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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Healx Limited
Study ID
NCT06541847
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Neurofibromatosis Type 1

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX-1502 — DRUG
    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).

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HLX-1502
    Participants will take an oral dose three times a day (with or without food) for 12 cycles. A cycle is defined as 28 days. Participants with a partial response or stable disease with a previously progressive tumor and/or clinical improvement can continue therapy for an additional 12 cycles for a total of 24 cycles.

Primary Outcome Measure

PN response rate [ Time Frame: 12 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Brian Roberts
[email protected]
Girish Dhall (PRINCIPAL_INVESTIGATOR)
Laura Katherine Metrock (SUB_INVESTIGATOR)
Children's Hospital Los AngelesLos AngelesCalifornia90027
Sandy Gutierrez
[email protected]
Tena Rosser (PRINCIPAL_INVESTIGATOR)
Nathan Robison (SUB_INVESTIGATOR)
Ashley Margol (SUB_INVESTIGATOR)
Tom Davidson (SUB_INVESTIGATOR)
Katrina O'Halloran (SUB_INVESTIGATOR)
Sara-Jane Oneyeama (SUB_INVESTIGATOR)
Anat Erdreich-Epstein (SUB_INVESTIGATOR)
Kaaren Waters (SUB_INVESTIGATOR)
Vless Trinidad (SUB_INVESTIGATOR)
Kasey Rangan (SUB_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Jenika Maala
[email protected]
Cynthia Campen (PRINCIPAL_INVESTIGATOR)
Sonia Partap (SUB_INVESTIGATOR)
Paul Fisher (SUB_INVESTIGATOR)
Katherine Ryan (SUB_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Sarah Dickens
[email protected]
Nicholas Foreman (PRINCIPAL_INVESTIGATOR)
Holly Lindsay (SUB_INVESTIGATOR)
Shelby Winzent-Oonk (SUB_INVESTIGATOR)
Molly Hemenway (SUB_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Grace Birmingham
[email protected]
Benjamin Siegel (PRINCIPAL_INVESTIGATOR)
Roger Packer (SUB_INVESTIGATOR)
Lindsay Kilburn (SUB_INVESTIGATOR)
AeRang Kim (SUB_INVESTIGATOR)
Amy Hont (SUB_INVESTIGATOR)
Liny John (SUB_INVESTIGATOR)
Brian Rood (SUB_INVESTIGATOR)
Eugene Hwang (SUB_INVESTIGATOR)
Holly Meany (SUB_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Miriam Bornhorst (PRINCIPAL_INVESTIGATOR)
Angela Waanders (SUB_INVESTIGATOR)
Ashley Plant (SUB_INVESTIGATOR)
Alicia Lenzen (SUB_INVESTIGATOR)
Maggie Seblani (SUB_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Cynthia MacKenzie
[email protected]
James Tonsgard (PRINCIPAL_INVESTIGATOR)
Shawn Damodharan (SUB_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Sara Quetant
[email protected]
Steven Rhodes (PRINCIPAL_INVESTIGATOR)
Scott Coven (SUB_INVESTIGATOR)
Jayne Vonbergen (SUB_INVESTIGATOR)
Brian Weiss (SUB_INVESTIGATOR)
Kathryn Nevel (SUB_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Joshua Roberts
[email protected]
Jaishri Blakeley (PRINCIPAL_INVESTIGATOR)
Shannon Langmead (SUB_INVESTIGATOR)
Carlos Romo (SUB_INVESTIGATOR)
Kelly Wypych (SUB_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Amy Armstrong (PRINCIPAL_INVESTIGATOR)
Angela Hirbe (SUB_INVESTIGATOR)
Brian Van Tine (SUB_INVESTIGATOR)
Mia Weiss (SUB_INVESTIGATOR)
Mohamed Abdelbaki (SUB_INVESTIGATOR)
Nicole Brossier (SUB_INVESTIGATOR)
Andrew Cluster (SUB_INVESTIGATOR)
Frederick Huang (SUB_INVESTIGATOR)
Allison King (SUB_INVESTIGATOR)
Bryan Sisk (SUB_INVESTIGATOR)
Daniel Willis (SUB_INVESTIGATOR)
David Wilson (SUB_INVESTIGATOR)
Sanita Burgic (SUB_INVESTIGATOR)
Linda Goldenberg (SUB_INVESTIGATOR)
Loren Abernathy (SUB_INVESTIGATOR)
Christina Carey (SUB_INVESTIGATOR)
Leslie Glover (SUB_INVESTIGATOR)
Ashley Meyer (SUB_INVESTIGATOR)
Andrea Ogle (SUB_INVESTIGATOR)
Camille Skaer (SUB_INVESTIGATOR)
Molly Warner (SUB_INVESTIGATOR)
New York University Langone HealthNew YorkNew York10016
Kaleb Yohay (PRINCIPAL_INVESTIGATOR)
Jessica Clymer (SUB_INVESTIGATOR)
Devorah Segal (SUB_INVESTIGATOR)
Jordie Blum (SUB_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter De Blank (PRINCIPAL_INVESTIGATOR)
Erin Breese (SUB_INVESTIGATOR)
Karen Burns (SUB_INVESTIGATOR)
Ellen Chang (SUB_INVESTIGATOR)
Richard Graham (SUB_INVESTIGATOR)
Trent Hummel (SUB_INVESTIGATOR)
LaQuita Jones (SUB_INVESTIGATOR)
Lynn Lee (SUB_INVESTIGATOR)
Benjamin Mizukawa (SUB_INVESTIGATOR)
Aaron Mochizuki (SUB_INVESTIGATOR)
Robin Norris (SUB_INVESTIGATOR)
John Perentesis (SUB_INVESTIGATOR)
Christine Phillips (SUB_INVESTIGATOR)
Natasha Pillay-Smiley (SUB_INVESTIGATOR)
Jonathan Bender (SUB_INVESTIGATOR)
Thomas Galletta (SUB_INVESTIGATOR)
Joseph Pressey (SUB_INVESTIGATOR)
Lauren Pommert (SUB_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Ratnakar Patti
[email protected]
Michael Fisher (PRINCIPAL_INVESTIGATOR)
Jean Belasco (SUB_INVESTIGATOR)
Stephanie Brosius (SUB_INVESTIGATOR)
Kristina Cole (SUB_INVESTIGATOR)
Jessica Foster (SUB_INVESTIGATOR)
Cassie Kline (SUB_INVESTIGATOR)
Chelsea Kotch (SUB_INVESTIGATOR)
Jane Minturn (SUB_INVESTIGATOR)
Amish Shah (SUB_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Laura Klesse (PRINCIPAL_INVESTIGATOR)
Justin Jordan (SUB_INVESTIGATOR)
Michael Youssef (SUB_INVESTIGATOR)
Evan Noch (SUB_INVESTIGATOR)
Elizabeth Maher (SUB_INVESTIGATOR)
Daniel Bowers (SUB_INVESTIGATOR)
Jonathan Wickiser (SUB_INVESTIGATOR)
Alexis Kennedy (SUB_INVESTIGATOR)
Devon Knotts (SUB_INVESTIGATOR)

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