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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Single group
Treatments tested in this trial
FCN-159
DrugFCN-159 8mg qd po
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: FCN-159Experimental treatment 1 intervention
Trial outcomes
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)
Time frame
Every 4 cycles (each cycle is 28 days), assessed up to 2 yearsSecondary outcomes
1
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)
Time frame
Every 4 cycles (each cycle is 28 days), assessed up to 2 years2
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).
Time frame
up to 24 weeks3
pain estimated by NRS
Change in pain intensity score relative to baseline will be assessed according to NRS scale.
Time frame
Every 4 cycles (each cycle is 28 days), assessed up to 2 years4
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.
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 yearsOther outcomes
1
life quality assessed by NFTI-QOL
Change in quality of life scores relative to baseline will be assessed by Neurofibromatosis type 2 impact on quality of life (NFTI-QOL) score. The higher score means worse life quality.
Time frame
Every 4 cycles (each cycle is 28 days), assessed up to 2 years2
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Adverse events during treatment of FCN-159 will be assessed by the investigators accroding to CTCAE 5.0.
Time frame
During the interventionSponsors and contacts
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Source ClinicalTrials.gov