Actively Recruiting
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-29
30
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.
CONDITIONS
Official Title
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older, any gender
- Diagnosed with NF2-associated nerve sheath tumors by 2022 criteria or pathology
- Have either incomplete surgical removal, tumor recurrence, or need systemic therapy
- Have a measurable lesion as defined by REiNS or RECIST V1.1
- Karnofsky performance score of 70 or higher
- Adequate organ and bone marrow function
- INR and APTT less than or equal to 1.5 times the upper limit of normal
- For those able to have children: agree to use highly effective contraception during and for 90 days after treatment
- Willing to avoid excessive sun exposure and use sunscreen
- Able to understand and sign informed consent
You will not qualify if you...
- Received pharmaceutical or biological therapy within 3 weeks or 5 half-lives before enrollment
- Used growth factors affecting blood cells within 7 days before enrollment
- Had major surgery or anti-tumor immunotherapy within 4 weeks before enrollment
- Received radiation therapy for nerve sheath tumors within 4 weeks before enrollment
- Had corticosteroid dose adjustments within 1 week before enrollment
- Participated in another interventional clinical trial within 4 weeks before enrollment
- Prior treatment with Selumetinib or other MEK 1/2 inhibitors
- History or current presence of other cancers
- Unable or contraindicated for MRI
- Uncontrolled high blood pressure
- Presence of swallowing difficulties, active gastrointestinal disease, malabsorption, or conditions affecting drug absorption
- Previous or current retinal vascular disease
- Interstitial pneumonitis
- Cardiac problems or co-existing illnesses
- Immediate family history of sudden cardiac death before age 50
- History of acute neurological conditions
- Active infections (bacterial, fungal, or viral)
- Known allergy to FCN-159, MEK1/2 inhibitors, or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shuhang Wang
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
N
Ning Li, M.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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