Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
ConditionNerve Sheath Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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.
Eligibility criteria
Qualifiers
≥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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- FCN-159
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov