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Идёт набор NCT05356741

To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Фаза I / Фаза II С лечением Locally Advanced or Metastatic HER2-Expressing Cancers

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: VIR-5818, pembrolizumab.
Кому может быть актуально
Состояния в реестре: Locally Advanced or Metastatic HER2-Expressing Cancers. 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
Австралия, Франция, Португалия, Испания
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 Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Обзор

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: * Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.

Вмешательства

  • Препарат VIR-5818
    Administered as IV infusion
  • Препарат pembrolizumab
    Administered as IV infusion

Первичные конечные точки

  • Incidence of dose-limiting toxicity - Part 1 and Part 2 [Срок оценки: Up to approximately 21 days (Part 1) and 42 days (Part 2)]
  • Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 [Срок оценки: Up to approximately 55 months]
  • Objective Response Rate (ORR) - Part 3 and Part 4 [Срок оценки: Up to approximately 55 months]
  • Duration of Response (DOR) - Part 3 and Part 4 [Срок оценки: Up to approximately 55 months]
Вторичные конечные точки (11)
  • ORR - Part 3 and Part 4 [Срок оценки: Up to approximately 55 months]
  • DOR - Part 3 and Part 4 [Срок оценки: Up to approximately 55 months]
  • Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Maximum plasma concentration (Cmax) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Minimum serum concentration (Cmin) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Clearance (CL) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Volume of distribution at steady-state (Vss) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Accumulation ratio [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • PK parameter: Half-life (t1/2) [Срок оценки: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months]
  • Incidence of anti-drug antibodies (ADAs) to VIR-5818 [Срок оценки: Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months]
  • All parts: Disease control rate (DCR) [Срок оценки: Up to approximately 55 months]

Критерии участия

Критерии включения

  • Written informed consent by the participant (or legally acceptable representative if applicable)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests

Критерии исключения

  • Significant cardiopulmonary disease and recent cardiac events
  • History of major organ autoimmune diseases
  • Acute or chronic infections

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 6 центров
  • Investigational site number #255 — Barcelona
  • Investigational site number #251 — Barcelona
  • Investigational site number #254 — Madrid
  • Investigational site number #252 — Madrid
  • Investigational site number #250 — Pamplona
  • Investigational site number #253 — Pozuelo de Alarcón
Австралия · 2 центра
  • Investigational site number #100 — Melbourne
  • Investigational site number #101 — Randwick
Франция · 1 центр
  • Investigational site number #150 — Toulouse
Португалия · 1 центр
  • Investigational site number #200 — Porto

Идентификаторы

NCT: NCT05356741 · VIR-5818-V101 · MK-3475-D14 · KEYNOTE-D14

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗