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Набор скоро начнётся NCT07708285

Luvometinib in Combination With Serplulimab for NF2-Related Tumors

Фаза I / Фаза II С лечением NF2-related Schwannomatosis NF2 Neurofibromatosis Type 2 Vestibular Schwannoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Luvometinib, Serplulimab.
Кому может быть актуально
Состояния в реестре: NF2-related Schwannomatosis, NF2, Neurofibromatosis Type 2, Vestibular Schwannoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Luvometinib
    Oral once daily per predetermined dosage per protocol.
  • Препарат Serplulimab
    Intravenous infusion per predetermined dosage per protocol.

Первичные конечные точки

  • Objective Response Rate (ORR) or Hearing Response Rate (HRR) [Срок оценки: 12 months]
Вторичные конечные точки (6)
  • Incidence of Adverse Events [Срок оценки: From first dose through 30 days after last dose (up to 12 months)]
  • Maximum Severity Grade of Adverse Events [Срок оценки: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Serious Adverse Events [Срок оценки: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Dose Modifications [Срок оценки: From first dose through 30 days after last dose (up to 12 months)]
  • Incidence of Treatment Interruptions [Срок оценки: From first dose through 30 days after last dose.]
  • Incidence of Treatment Discontinuations [Срок оценки: From first dose through 30 days after last dose.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 5 центров
  • Xuanwu Hospital, Capital Medical University — Пекин
  • Beijing Tiantan Hospital, Capital Medical University — Пекин
  • Chinese PLA General Hospital — Пекин
  • The First Hospital of Jilin University — Changchun
  • Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT07708285 · HX-A-2026035

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗