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New treatment option for Nerve Sheath Tumor
Official title Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
ClinicalTrials.gov ID: NCT06553365
What this study is testing
What is FCN-159?
FCN-159 is an investigational medicine, being studied as a potential treatment for nerve sheath tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join 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...
- the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
- Karnofsky physical status score of ≥70.
You likely can't join 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.
See the full eligibility criteria
- ≥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.
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.