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Clinical Trials in China / NCT07708285
Starting soon Phase 1/2

Luvometinib in Combination With Serplulimab for NF2-Related Tumors

NCT07708285 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Phase 1/2
Started
2026-07-31
Last updated
2026-07-16

Condition(s) studied

NF2-related SchwannomatosisNF2Neurofibromatosis Type 2Vestibular SchwannomaMeningioma

Investigational drug(s) / intervention(s)

LuvometinibSerplulimab

Luvometinib: Oral once daily per predetermined dosage per protocol.

Serplulimab: Intravenous infusion per predetermined dosage per protocol.

Study summary

This is an investigator-initiated, exploratory, multicenter, open-label, single-arm clinical trial and a substudy of the Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2). The study aims to evaluate the safety, tolerability, and preliminary efficacy of luvometinib in combination with serplulimab in patients with NF2-related schwannomatosis (NF2-SWN) with progressive tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Participants must meet the diagnostic criteria for NF2-SWN. 2. Presence of at least one measurable target tumor, either vestibular schwannoma or meningioma, with MRI-documented volumetric progression within the past 36 months or clinical symptom progression related to the target tumor. 3. The target tumor is considered unsuitable for surgery because of high risk. 4. Age \>=18 years at the time of screening. 5. KPS \>=70 or ECOG performance status 0 or 1. 6. Adequate organ function based on laboratory tests obtained within 14 days before screening. 7. Participant must be able to understand the study and voluntarily sign informed consent. Exclusion Criteria: 1. Pregnant, planning to become pregnant, or currently breastfeeding. 2. Participation in another interventional clinical trial within the past 4 weeks, or radiation therapy to target lesion(s) within the past 3 years. 3. Severe adverse reactions or intolerable toxicity from prior immune checkpoint inhibitors or MEK inhibitors. 4. Concomitant active malignancies, uncontrolled infections, or active autoimmune diseases. 5. Severe cardiac, hepatic, renal, gastrointestinal, or ophthalmic diseases. 6. Any other factor that may compromise participant safety or study integrity.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality
Chinese PLA General Hospital Beijing Beijing Municipality
The First Hospital of Jilin University Changchun Jilin
Shanghai General Hospital Shanghai Shanghai Municipality

More Beijing Tiantan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07708285 on ClinicalTrials.gov ↗ ← All trials in China