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Идёт набор NCT06589830

TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

Фаза II С лечением Colorectal Cancer Metastatic Advanced Colorectal Cancer

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: TL938 Capsules, Trastuzumab.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer Metastatic, Advanced Colorectal Cancer. 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
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Официальное название

A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer

Обзор

This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.

Вмешательства

  • Препарат TL938 Capsules
    Oral administration
  • Препарат Trastuzumab
    Intravenous (IV) infusion

Первичные конечные точки

  • Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Objective Response Rate (ORR) by IRC [Срок оценки: Pre-dose up to approximately 24 months post-dose]
Вторичные конечные точки (12)
  • Objective Response Rate (ORR) by Investigator [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Duration of Response (DoR) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Disease Control Rate (DCR) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Progression Free Survival (PFS) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Time to Tumor Progression (TTP) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Time to Treatment Failure (TTF) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Time to Response (TTR) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Overall Survival (OS) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • 1-year Progression Free Survival [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • 1-year Survival [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Number of Participants Experiencing Adverse Events (AE) [Срок оценки: Pre-dose up to approximately 24 months post-dose]
  • Number of Participants Experiencing Adverse Drug Reactions (ADR) [Срок оценки: Pre-dose up to approximately 24 months post-dose]

Критерии участия

Критерии включения

  • Age 18 years old and above, male or female;
  • Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;
  • At least one measurable lesion;
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
  • A minimum life expectancy of >3 months;
  • Adequate bone marrow reserve, hepatic, renal, and coagulation function;
  • Other inclusion criteria apply for participating in the Study. -

Критерии исключения

  • Prior anti-HER2 targeting therapy;
  • Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment;
  • Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
  • Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
  • Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
  • Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
  • Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast;
  • Any active infection which has not been controlled at screening;
  • Other exclusion criteria apply for participating in the Study. -

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06589830 · TL-HER-202301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗