Nerve Sheath TumorPhase 2NCT06553365
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
A Phase 2 study testing FCN-159 in people with Nerve Sheath Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nerve Sheath Tumor
- What is being tested?
- FCN-159
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥16 years of age, regardless of gender.
- meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.
- should meet one of the following criteria: 1) Incomplete surgical resection, or postoperative recurrence. 2) Systemic therapy is required as determined by the Investigator.
- the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
- Karnofsky physical status score of ≥70.
- the patient has adequate organ and bone marrow function.
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- International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- For patients of childbearing potential: During treatment and for at least 90 days after the last dose, patients should agree to use a highly effective method of contraception.
- avoid excessive sun exposure and be willing to use an adequate amount of sunscreen in anticipation of sun exposure.
- be able to understand and voluntarily sign a written informed consent form.
Who cannot join
- Previously received one of the following treatments:
- Pharmaceutical or biological therapy within 3 weeks or 5 half-lives prior to enrollment, whichever is longer.
- Use of growth factors that promote platelet, red blood cell, or white blood cell count or function within 7 days prior to enrollment.
- Patients who have received major surgery or anti-tumor immunotherapy within 4 weeks prior to enrollment.
- Radiation therapy for nerve sheath tumors within 4 weeks prior to enrollment.
- Dose adjustment for patients treated with dexamethasone or other corticosteroids within 1 week prior to enrollment.
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- Patients who have participated in another interventional clinical trial within 4 weeks prior to enrollment.
- Prior treatment with Selumetinib or any other MEK 1/2 inhibitor. 2. history of or concurrent with other malignancies. 3. inability to undergo MRI and/or contraindications to MRI. 4. uncontrolled hypertension. 5. the presence of dysphagia, active gastrointestinal disease, malabsorption syndrome, or other condition that interferes with the absorption of the study medication.
- 6. previous or current retinal vascular disease. 7. interstitial pneumonitis 8. cardiac function or co-morbidities 9. Immediate family history of sudden cardiac death before age 50. 10.History of any acute neurological condition 11. with active bacterial, fungal or viral infections 12. known hypersensitivity to the study drug, other MEK1/2 inhibitors, or their excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shuhang Wang
Beijing, Beijing Municipality, 100021
Shuhang Wang, 13581809307
About this study
Official title: An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors
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.
Read the detailed description
- A phase 2 single arm single center study, total 30 patients will be enrolled;
- To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2; associated nerve sheath tumors, age≥16, including benign and malignant tumors;
- Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical benefit rate (CBR)；24w WRS, OS et al..
- Conditions
- Nerve Sheath Tumor
- Being tested
- FCN-159
- Keywords
- MEK, NF2, nerve sheath tumor
- Medical subject headings
- Nerve Sheath Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-159Drug
FCN-159 8mg qd po
| Study group | Role | What they receive |
|---|---|---|
| FCN-159 | Experimental | FCN-159 8mg qd po Receives: Drug: FCN-159 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) estimated by investigators
Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively)
Measured: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Secondary outcomes (5)
Clinical benefit rate (CBR) estimated by investigators
Clinical benefit rate CBR will be assessed by the investigator (REiNS criteria and RECIST 1.1 criteria respectively)
Measured: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
24-week word recognition score (WRS)
Hearing response changes will be assessed in patients with hearing impairment (24-week word recognition scores and pure tone audiometry).
Measured: up to 24 weeks
pain estimated by NRS
Change in pain intensity score relative to baseline will be assessed according to NRS scale.
Measured: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Duration of response (DOR) assessed by investigator
Duration of response (DoR) is estimated by the investigators as the time from treatment initiation to disease progression or death in patients who achieve complete or partial response, using both RECIST V1.1 and REINS criteria.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
progression free survival (PFS) assessed by investigator
PFS is estimated by the investigators as the time from treatment initiation to disease progression or death in patients, using both RECIST V1.1 and REINS criteria.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Sheath TumorStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhang wang, PhD, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553365
- Sponsor's protocol ID
- FCN-159-IIT02
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the decision will be made after the primary analysis of results.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-Arm Phase II Study Evaluating the Efficacy and Safety of FCN-159 in Selected NF2-associated Nerve Sheath Tumors
- ClinicalTrials.gov ID
- NCT06553365
- Acronym / sponsor ID
- FCN-159-IIT02
- Conditions
- Nerve Sheath Tumor
- Keywords
- MEK, NF2, nerve sheath tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- A phase 2 single arm single center study, total 30 patients will be enrolled;
- To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2; associated nerve sheath tumors, age≥16, including benign and malignant tumors;
- Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical benefit rate (CBR)；24w WRS, OS et al..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCN-159 | Experimental | Drug: FCN-159FCN-159 8mg qd po |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- ≥16 years of age, regardless of gender.
- meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.
- should meet one of the following criteria: 1) Incomplete surgical resection, or postoperative recurrence. 2) Systemic therapy is required as determined by the Investigator.
- the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
- Karnofsky physical status score of ≥70.
Key exclusion criteria (9 listed)
- Previously received one of the following treatments:
- 6. previous or current retinal vascular disease. 7. interstitial pneumonitis 8. cardiac function or co-morbidities 9. Immediate family history of sudden cardiac death before age 50. 10.History of any acute neurological condition 11. with active bacterial, fungal or viral infections 12. known hypersensitivity to the study drug, other MEK1/2 inhibitors, or their excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCN-159FCN-159 8mg qd po | Drug | FCN-159 |
Primary outcome
Objective response rate (ORR) estimated by investigators
Time frame: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively)
5 secondary outcomes
Clinical benefit rate (CBR) estimated by investigators
Time frame: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
24-week word recognition score (WRS)
Time frame: up to 24 weeks
pain estimated by NRS
Time frame: Every 4 cycles (each cycle is 28 days), assessed up to 2 years
Duration of response (DOR) assessed by investigator
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
progression free survival (PFS) assessed by investigator
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. the decision will be made after the primary analysis of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuhang wang, PhD study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FCN-159 in people with Nerve Sheath Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, M.D. (+86 135-5271-5820, yalejiang@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) estimated by investigators (time frame: Every 4 cycles (each cycle is 28 days), assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.