Luvometinib in Combination With Serplulimab for NF2-Related Tumors

NCT07708285 | Not Yet Recruiting Phase 1

• 1 other identifier: HX-A-2026035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

NF2-related Schwannomatosis; NF2; Neurofibromatosis Type 2; Vestibular Schwannoma; Meningioma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) or Hearing Response Rate (HRR)

  Vestibular schwannoma: HRR is defined as WRS improvement exceeding the 95% critical difference from baseline; if baseline WRS is \<20%, HRR is defined as a PTA decrease of at least 10 dB. Meningioma: ORR is defined as at least a 20% reduction in target tumor volume from baseline.

  12 months

Secondary Outcomes (6)

• Incidence of Adverse Events

  From first dose through 30 days after last dose (up to 12 months)

• Maximum Severity Grade of Adverse Events

  From first dose through 30 days after last dose (up to 12 months)

• Incidence of Serious Adverse Events

  From first dose through 30 days after last dose (up to 12 months)

• Incidence of Dose Modifications

  From first dose through 30 days after last dose (up to 12 months)

• Incidence of Treatment Interruptions

  From first dose through 30 days after last dose.

Study Arms (1)

Luvometinib + Serplulimab

EXPERIMENTAL

Subjects will receive luvometinib 8 mg by mouth once daily in combination with serplulimab 4.5 mg/kg intravenously every 3 weeks for up to 12 cycles (28 days per cycle).

Drug: Luvometinib; Drug: Serplulimab

Interventions

Luvometinib DRUG

Oral once daily per predetermined dosage per protocol.

Also known as: FCN-159

Luvometinib + Serplulimab

Serplulimab DRUG

Intravenous infusion per predetermined dosage per protocol.

Also known as: HLX10

Luvometinib + Serplulimab

Eligibility Criteria

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

You may qualify if:

• Participants must meet the diagnostic criteria for NF2-SWN.
• 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.
• The target tumor is considered unsuitable for surgery because of high risk.
• Age \>=18 years at the time of screening.
• KPS \>=70 or ECOG performance status 0 or 1.
• Adequate organ function based on laboratory tests obtained within 14 days before screening.
• Participant must be able to understand the study and voluntarily sign informed consent.

You may not qualify if:

• Pregnant, planning to become pregnant, or currently breastfeeding.
• Participation in another interventional clinical trial within the past 4 weeks, or radiation therapy to target lesion(s) within the past 3 years.
• Severe adverse reactions or intolerable toxicity from prior immune checkpoint inhibitors or MEK inhibitors.
• Concomitant active malignancies, uncontrolled infections, or active autoimmune diseases.
• Severe cardiac, hepatic, renal, gastrointestinal, or ophthalmic diseases.
• Any other factor that may compromise participant safety or study integrity.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (5)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Neurofibromatosis 2; Neuroma, Acoustic; Meningioma

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neuroma; Neoplastic Syndromes, Hereditary; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 16, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)