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New treatment option for Neurofibromatosis 1
Official title HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas
ClinicalTrials.gov ID: NCT05331105
What this study is testing
What is HL-085?
HL-085 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neurofibromatosis 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Multi-center, Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of HL-085 in the treatment of Adult Participants with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas(PN)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age: patients must be ≥18 years of age at the time of study entry.
- Diagnosis: Patients must have inoperable and symptomatic plexiform neurofibromas(PN), and patients must have NF1 mutation or meet at least 1 of the...
- Patients must have a measurable lesion, defined as at least 3 cm in length, amenable to MRI for how well it works assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients are able to understand and voluntarily sign a written informed consent form.
You likely can't join if
- Patients who are unable to undergo MRI scans (prosthesis, prosthesis, braces, etc.) or patients with lesions that cannot be evaluated by MRI.
- Patients do not have adequate organ function.
- Patients who are unable to take drugs orally, have difficulty swallowing or anything that may lead to inadequate drug absorption.
- Prior treatment with MEK 1/2 inhibitors.
- Patients known to be allergic to the ingredients or analogues of the study drug.
- Patients with previous or current retinal diseases such as retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), central serous...
See the full eligibility criteria
- Age: patients must be ≥18 years of age at the time of study entry.
- Diagnosis: Patients must have inoperable and symptomatic plexiform neurofibromas(PN), and patients must have NF1 mutation or meet at least 1 of the following NF1 diagnostic criteria: ① ≥6 cafe-au-lait macules ; ②...
- Patients must have a measurable lesion, defined as at least 3 cm in length, amenable to MRI for how well it works assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients are able to understand and voluntarily sign a written informed consent form.
- Patients must be willing and able to complete study procedures and follow-up examinations.
- Patients who are unable to undergo MRI scans (prosthesis, prosthesis, braces, etc.) or patients with lesions that cannot be evaluated by MRI.
- Patients do not have adequate organ function.
- Patients who are unable to take drugs orally, have difficulty swallowing or anything that may lead to inadequate drug absorption.
- Prior treatment with MEK 1/2 inhibitors.
- Patients known to be allergic to the ingredients or analogues of the study drug.
- Patients with previous or current retinal diseases such as retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), central serous retinopathy (CSR), etc. (except retinopathy caused by research...
- With infections or other uncontrolled disease.
- Strong CYP2C9 inhibitors or inducers within 7 days before treatment of the study drug.
- Patients who received surgery within 4 weeks or radiotherapy within 6 weeks before enrollment.
- Patients who participated in any other clinical study treatment within 4 weeks before enrollment.
- Patients treated with anti-NF1 treatment with unresolved chronic toxicity.
- Clinical judgment by the investigator that the patient should not participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.