Actively Recruiting
HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas
Led by Shanghai Kechow Pharma, Inc. · Updated on 2023-05-31
70
Participants Needed
1
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older at study entry
- Diagnosis of inoperable and symptomatic plexiform neurofibromas with NF1 mutation or meeting at least one NF1 diagnostic criterion (six or more cafe-au-lait spots, axillary or inguinal freckling, two or more Lisch nodules, distinctive bony lesion, optic pathway glioma, or first-degree relative with NF1)
- Presence of a measurable lesion at least 3 cm in length suitable for MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to understand and voluntarily sign informed consent
- Willingness and ability to complete study procedures and follow-up examinations
You will not qualify if you...
- Inability to undergo MRI scans or lesions not evaluable by MRI
- Inadequate organ function
- Inability to take oral medication or difficulty swallowing
- Prior treatment with MEK 1/2 inhibitors
- Known allergy to the study drug or its analogues
- Current or previous retinal diseases such as retinal vein occlusion, retinal pigment epithelium detachment, or central serous retinopathy (except retinopathy caused by study disease)
- Active infections or uncontrolled diseases
- Use of strong CYP2C9 inhibitors or inducers within 7 days before study drug treatment
- Surgery within 4 weeks or radiotherapy within 6 weeks before enrollment
- Participation in another clinical study treatment within 4 weeks before enrollment
- Treatment with anti-NF1 therapy with unresolved chronic toxicity
- Investigator judgment that participation is not appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
Z
Zhimei Zhu, Master
CONTACT
H
Hongqi Tian, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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