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Идёт набор NCT07612891

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor

Фаза I / Фаза II С лечением Breast Cancer (Locally Advanced or Metastatic) Advanced Solid Cancers Metastatic (Stage IV) Breast Cancer Ovarian 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: INV-6452.
Кому может быть актуально
Состояния в реестре: Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian 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
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 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor

Обзор

This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic solid tumor.

Вмешательства

  • Препарат INV-6452
    once daily orally

Первичные конечные точки

  • Phase 1: Maximum tolerated dose (MTD) [Срок оценки: Within first 28 days of treatment]
  • Phase 1: Recommended dose range (RDR) [Срок оценки: 12 months]
  • Phase 2: Evaluate overall response rate (ORR) [Срок оценки: 12 months]
Вторичные конечные точки (2)
  • Phase 1: Determine the pharmacokinetics (PK) using AUC of INV-6452 [Срок оценки: 12 months for Phase 1]
  • Phase 2: Determine the PK using AUC of INV-6452 [Срок оценки: 12 months for Phase 2]

Критерии участия

Критерии включения

  • Written informed consent obtained.
  • Adult patients aged ≥ 18 years.
  • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+/HER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors).
  • Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).
  • Have RECIST 1.1-defined measurable lesions.
  • Has a life expectancy of > 3 months.
  • ECOG performance status 0-1.
  • Adequate marrow, liver and kidney function.
  • Meet the study's specified contraceptive requirements.

Критерии исключения

  • Have a second primary malignancy.
  • Patients with primary CNS tumors or CNS metastases with prior local treatment failure.
  • Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.
  • Has undergone major surgery within 28 days prior to the first dose of study drug.
  • Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.
  • Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.
  • Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
  • Have protocol-defined clinically significant cardiovascular diseases.
  • Prolonged QTcF interval.
  • Have any medical conditions likely to impair digestion and absorption of the investigational product.
  • Patients with poorly managed blood glucose levels and blood pressure.
  • Clinically significant abnormal serum potassium or sodium as judged by the investigator.
  • Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.
  • Confirmed infection with HIV, HBV or HCV.
  • Are currently receiving any other investigation agent.
  • Have received prior CDK2 inhibitors.
  • Patients with known hypersensitivity to the study drug or any of its components.
  • History of allogenic tissue or solid organ transplant.
  • Are unwilling or unable to comply with procedures required in this protocol.
  • Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07612891 · INV-6452-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗