Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors

NCT06553365 | Recruiting Phase 2

• 1 other identifier: FCN-159-IIT02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nerve Sheath Tumor

Keywords

MEK; NF2; nerve sheath tumor

Outcome Measures

Primary Outcomes (1)

• 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)

  Every 4 cycles (each cycle is 28 days), assessed up to 2 years

Secondary Outcomes (5)

• Clinical benefit rate (CBR) estimated by investigators

  Every 4 cycles (each cycle is 28 days), assessed up to 2 years

• 24-week word recognition score (WRS)

  up to 24 weeks

• pain estimated by NRS

  Every 4 cycles (each cycle is 28 days), assessed up to 2 years

• Duration of response (DOR) assessed by investigator

  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

  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

Other Outcomes (2)

• life quality assessed by NFTI-QOL

  Every 4 cycles (each cycle is 28 days), assessed up to 2 years

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0

  During the intervention

Study Arms (1)

FCN-159

EXPERIMENTAL

FCN-159 8mg qd po

Drug: FCN-159

Interventions

FCN-159 DRUG

FCN-159 8mg qd po

FCN-159

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.
• 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.

You may not qualify if:

• 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.
• 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.
• \. 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Shuhang Wang

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Nerve Sheath Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Shuhang wang, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Ning Li, M.D.

CONTACT

+86 135-5271-5820; yalejiang@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 14, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)