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MEK1/2 inhibitor
FCN-159 for Neurofibromatosis
Phase 1 & 2
Waitlist Available
Research Sponsored by Shanghai Fosun Pharmaceutical Development Co, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1: 16-70 years of age with a body weight of ≥ 94 lbs or 42.5 kg
Participants must have a Karnofsky performance level of ≥70% (adults) or Lansky performance score ≥ 70% (pediatric participants)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, FCN-159, to see if it can help treat patients with advanced solid tumors or neurofibromatosis type 1.
Who is the study for?
This trial is for adults and children with Neurofibromatosis Type 1 (NF1) who have plexiform neurofibromas (PNs). Adults must be aged 16-70, weigh at least 94 lbs, and children should be aged 2-15. Participants need to have a measurable lesion suitable for MRI scans, not had certain treatments recently, can swallow tablets whole, and agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests FCN-159's safety and effectiveness against tumors caused by NF1. FCN-159 is an oral drug designed as a MEK1/2 inhibitor targeting advanced solid tumors. The trial will assess how well it tolerates in different age groups and its impact on tumor size.See study design
What are the potential side effects?
While the specific side effects of FCN-159 are not listed here, similar drugs often cause skin rash, diarrhea, fatigue or weakness. There may also be risks of eye problems like blurred vision or other organ-specific issues due to the inhibition of MEK pathways.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 16 and 70 years old and weigh at least 94 lbs (42.5 kg).
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have been diagnosed with neurofibromatosis type 1 (NF1).
Select...
I have a tumor that is at least 3 cm big and can be seen on an MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Safety: Dose-limiting toxicity (DLT) incidence rate.
Phase I: Safety: MTD and RP2D.
Phase II: Objective response rate (ORR) by BIRC assessment
Secondary outcome measures
Phase I Changes in NF1-related symptoms.
Phase I Clinical outcome variables: patient- and observer-reported outcomes and functional measures
Phase I Efficacy: objective response rate (ORR) by investigator /BIRC assessment, clinical benefit rate (CBR) per investigator/BIRC assessment including CR, PR, and SD lasting more than 6 months;
+16 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Shanghai Fosun Pharmaceutical Development Co, Ltd.Lead Sponsor
4 Previous Clinical Trials
723 Total Patients Enrolled
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Lead Sponsor
14 Previous Clinical Trials
4,925 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurofibroma that has grown along a nerve.I have not had radiotherapy, surgery, or immunotherapy in the last 4 weeks.I have swallowing difficulties or digestive problems that affect how my body absorbs food.I will avoid too much sun and use sunscreen if I'm in the sun.I am allergic to the study drug or similar medications.My NF1 causes or could cause serious health problems.I am between 16 and 70 years old and weigh at least 94 lbs (42.5 kg).My spinal nerve condition affects multiple levels and is connected or extends sideways.I have had issues with my eyes, like retinal vein occlusion or glaucoma.I have a unique bone condition affecting my skull or long bones.My high blood pressure is not under control.My NF1-related tumor needs treatment like chemo, radiation, or surgery.I have not used growth factors in the week before starting FCN-159.I have not been treated with selumetinib or any MEK 1/2 inhibitors.I have NF1 with plexiform neurofibromas needing treatment as advised by my doctor.I do not have serious heart problems or other major diseases.I have interstitial pneumonia.I do not have any ongoing infections.I haven't taken certain medications in the last 14 days.I've had chemotherapy for NF1 within the last 3 months and still experience significant side effects.I am mostly able to care for myself and carry out daily activities.I am between 2 and 15 years old and can swallow a tablet whole.I have been diagnosed with neurofibromatosis type 1 (NF1).I have a tumor that is at least 3 cm big and can be seen on an MRI.I have freckles under my arms or in the groin area.I have been diagnosed with neurofibromatosis type 1.You have at least 2 Lisch nodules (iris hamartomas).You need to meet at least one of the following criteria:I will avoid too much sun and use sunscreen if needed.I have two or more neurofibromas or at least one plexiform neurofibroma.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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