Luvometinib in Combination With Serplulimab for NF2-Related Tumors

ClinicalTrials.gov ID

NCT07708285

Lead Sponsor

Beijing Tiantan HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

30Estimated

Last Update Posted

Jul 16, 2026Actual

Start Date

Jul 31, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

A Multicenter, Open-Label Study of Luvometinib in Combination With Serplulimab for the Treatment of NF2-Related Tumors

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.

Detailed Description

NF2-related schwannomatosis (NF2-SWN) is a rare autosomal dominant disorder characterized by multiple central nervous system tumors, most commonly vestibular schwannomas and meningiomas. Although current treatments such as surgery and radiotherapy can provide disease control, they are not curative and are associated with cumulative neurological morbidity and potential risk of secondary malignancies. There remains a significant unmet need for effective systemic therapies.

This investigator-initiated study is conducted as a substudy within the Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2). The trial evaluates luvometinib in combination with serplulimab in patients with progressive NF2-SWN.

Luvometinib (FCN-159) is a selective MEK1/2 inhibitor with antitumor activity in NF1-associated tumors. Serplulimab (HLX10) is an anti-PD-1 monoclonal antibody approved for multiple solid tumors. Preclinical evidence suggests that MEK inhibition may enhance tumor immunogenicity and synergize with immune checkpoint blockade.

The study aims to assess the safety, tolerability, and preliminary efficacy of this combination in NF2-SWN.

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

• Luvometinib
• Serplulimab

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Beijing Tiantan HospitalOTHER

junzhang301@163.com86+ 10-68182255

yunqian@jlu.edu.cn86+ 431-88782222

loumq68128@hotmail.com+86 21-63846590

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