HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Kechow Pharma, Inc.
About this trial
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)
Eligibility criteria
Qualifiers
Age: patients must be ≥18 years of age at the time of study entry.
Patients must have a measurable lesion, defined as at least 3 cm in length, amenable to MRI for efficacy assessment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Patients are able to understand and voluntarily sign a written informed consent form.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HL-085
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov