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Идёт набор NCT07151040

Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

Фаза I / Фаза II С лечением Solid Tumor Colorectal Cancer (CRC) Squamous Cell Carcinoma of Head and Neck Non-Small Cell Lung Cancer (NSCLC)

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: TH9619.
Кому может быть актуально
Состояния в реестре: Solid Tumor, Colorectal Cancer (CRC), Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer (NSCLC). 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
Франция, Испания, Великобритания
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 First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors

Обзор

This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.

Вмешательства

  • Препарат TH9619
    Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available.

Первичные конечные точки

  • Frequency of treatment-emergent adverse events (TEAEs) [Срок оценки: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading [Срок оценки: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator [Срок оценки: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Frequency of serious adverse events (SAEs) [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol. [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator [Срок оценки: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]
  • Incidence of findings during physical examinations assessed as clinically significant by the Investigator [Срок оценки: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.]

Критерии участия

Критерии включения

  • Must have given written informed consent
  • Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer))
  • Prior treatment with at least one line of cytotoxic systemic therapy for metastatic/unresectable cancer
  • Adult patients (≥18 years of age)
  • Must be willing to comply with study procedures

Критерии исключения

  • History or presence of any clinically significant disorders as judged by the Investigator.

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

Испания · 2 центра
  • Vall D Hebron Institute Of Oncology — Barcelona
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid
Франция · 1 центр
  • Institut Gustave Roussy — Villejuif
Великобритания · 1 центр
  • Newcastle University — Newcastle upon Tyne

Идентификаторы

NCT: NCT07151040 · TH9619-0101 · 2024-519639-40-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗