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Luvometinib in Combination With Serplulimab for NF2-Related Tumors

14. juli 2026 opdateret af: Beijing Tiantan Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Chinese PLA General Hospital
        • Kontakt:
      • Beijing, Beijing Municipality, Kina, 100070
        • Beijing Tiantan Hospital, Capital Medical University
        • Kontakt:
      • Beijing, Beijing Municipality, Kina, 100053
        • Xuanwu Hospital, Capital Medical University
        • Kontakt:
    • Jilin
      • Changchun, Jilin, Kina
        • The First Hospital of Jilin University
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200080
        • Shanghai General Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Luvometinib + Serplulimab
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).
Medicin: Luvometinib
Oral once daily per predetermined dosage per protocol.
Andre navne:
  • FCN-159
Medicin: Serplulimab
Intravenous infusion per predetermined dosage per protocol.
Andre navne:
  • HLX10

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR) or Hearing Response Rate (HRR)
Tidsramme: 12 months

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events
Tidsramme: From first dose through 30 days after last dose (up to 12 months)
Percentage of participants who experience at least one adverse event. Adverse events will be coded and graded according to NCI CTCAE v5.0.
From first dose through 30 days after last dose (up to 12 months)
Maximum Severity Grade of Adverse Events
Tidsramme: From first dose through 30 days after last dose (up to 12 months)
Maximum NCI CTCAE v5.0 grade of adverse events experienced by each participant during the reporting period.
From first dose through 30 days after last dose (up to 12 months)
Incidence of Serious Adverse Events
Tidsramme: From first dose through 30 days after last dose (up to 12 months)
Percentage of participants who experience at least one serious adverse event.
From first dose through 30 days after last dose (up to 12 months)
Incidence of Dose Modifications
Tidsramme: From first dose through 30 days after last dose (up to 12 months)
Percentage of participants who require at least one dose modification due to an adverse event.
From first dose through 30 days after last dose (up to 12 months)
Incidence of Treatment Interruptions
Tidsramme: From first dose through 30 days after last dose.
Percentage of participants who require at least one treatment interruption due to an adverse event.
From first dose through 30 days after last dose.
Incidence of Treatment Discontinuations
Tidsramme: From first dose through 30 days after last dose.
Percentage of participants who discontinue study treatment due to an adverse event.
From first dose through 30 days after last dose.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Tiantan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HX-A-2026035

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Meningiom

Kliniske forsøg med Luvometinib

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