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NF2-related SchwannomatosisPhase 1/2NCT07708285

Luvometinib in Combination With Serplulimab for NF2-Related Tumors

A Phase 1/2 study testing Luvometinib and Serplulimab in people with NF2-related Schwannomatosis and NF2, run by Beijing Tiantan Hospital at 5 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Luvometinib and Serplulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesChina
Study dates
31 Jul 2026to 31 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

China5 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Hao Wu, MD, PhD, +86 10-83922345, wuhaospine@xwh.ccmu.edu.cn

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

    Pinan Liu, MD, PhD, 86+ 10-59976611, pinanliu@ccmu.edu.cn

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Jun Zhang, MD, PhD, 86+ 10-68182255, junzhang301@163.com

  • The First Hospital of Jilin University

    Changchun, Jilin

    Yunqian Li, MD, PhD, 86+ 431-88782222, yunqian@jlu.edu.cn

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Meiqing Lou, MD, PhD, +86 21-63846590, loumq68128@hotmail.com

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Luvometinib, Serplulimab
Medical subject headings
Neurofibromatosis 2, Neuroma, Acoustic, Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LuvometinibDrug

    Also called FCN-159

    Oral once daily per predetermined dosage per protocol.

  • SerplulimabDrug

    Also called HLX10

    Intravenous infusion per predetermined dosage per protocol.

Study groups in NCT07708285
Study groupRoleWhat they receive
Luvometinib + SerplulimabExperimentalSubjects 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).
Receives: Drug: Luvometinib; Drug: Serplulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (6)

  1. Incidence of Adverse Events

    Percentage of participants who experience at least one adverse event. Adverse events will be coded and graded according to NCI CTCAE v5.0.

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

  2. Maximum Severity Grade of Adverse Events

    Maximum NCI CTCAE v5.0 grade of adverse events experienced by each participant during the reporting period.

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

  3. Incidence of Serious Adverse Events

    Percentage of participants who experience at least one serious adverse event.

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

  4. Incidence of Dose Modifications

    Percentage of participants who require at least one dose modification due to an adverse event.

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

  5. Incidence of Treatment Interruptions

    Percentage of participants who require at least one treatment interruption due to an adverse event.

    Measured: From first dose through 30 days after last dose.

  6. Incidence of Treatment Discontinuations

    Percentage of participants who discontinue study treatment due to an adverse event.

    Measured: From first dose through 30 days after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start31 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708285
Sponsor's protocol ID
HX-A-2026035
Status last verified
Jun 2026
First submitted
3 Jul 2026
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Luvometinib and Serplulimab in people with NF2-related Schwannomatosis and NF2, run by Beijing Tiantan Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) or Hearing Response Rate (HRR) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07708285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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