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Идёт набор NCT06520488

A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors

Фаза I / Фаза II С лечением Advanced Solid Tumors

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: HRS-4642.
Кому может быть актуально
Состояния в реестре: Advanced Solid Tumors. Базовые параметры: 18 лет — 75 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

Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of HRS-4642 in Combination With Anti-tumor Agents in Subjects With Advanced Solid Tumors

Обзор

To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).

Вмешательства

  • Препарат HRS-4642
    Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904 Treatment group Part II: HRS-4642 combined with AG

Первичные конечные точки

  • Stage 1: (IB Period):DLTs [Срок оценки: Within 28 days of the first dose]
  • Stage 1: (IB Period): adverse events (AEs) [Срок оценки: Within 28 days of the first dos,About 1 year]
  • Phase II: (Phase II):investigator-assessed ORR [Срок оценки: Assessed every 6 weeks,About 1 year]
Вторичные конечные точки (7)
  • Stage 1: (IB Period):Investigator-assessed objective response rate (ORR) [Срок оценки: Assessed every 6 weeks,About 1 year]
  • Phase II: (Phase II):DCR [Срок оценки: Assessed every 6 weeks,About 1 year]
  • Phase II: (Phase II):DoR [Срок оценки: Assessed every 6 weeks,About 1 year]
  • Phase II: (Phase II):OS [Срок оценки: Assessed every 6 weeks+ About 1 year]
  • Phase II: (Phase II):PFS [Срок оценки: Assessed every 6 weeks,About 1 year]
  • Phase II: (Phase II):OS [Срок оценки: Assessed approximately once every 1 month,About 1 year]
  • Phase II: (Phase II):Incidence and severity of AEs [Срок оценки: Assessed approximately once every 1 month,About 1 year]

Критерии участия

Критерии включения

  • Able and willing to provide a written informed consent
  • Age 18-75 years old (inclusive) at the time of signing the informed consent form
  • Male or female
  • ECOG score of 0 or 1
  • Expected survival ≥ 12 weeks
  • At least one measurable lesion according to RECIST v1.1 criteria

Критерии исключения

  • Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
  • Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
  • Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
  • Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
  • Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter
  • Use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment
  • Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
  • Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated
  • Active hepatitis B
  • Presence of clinically significant acute or chronic pancreatitis
  • Poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry
  • Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved

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 · 1 центр
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Публикации

  • Cui J, Jiang K, Li W, Ni S, Zong H, Du J, He Y, Liu Z, Kong G, Zhang Y, Li X, Han H, Yao F, Chen Y, Zhou M, Wang L. KRAS-G12D inhibitor HRS-4642 plus chemotherapy in advanced KRASG12D-mutant pancreatic cancer: a phase 1b/2 trial. Nat Med. 2026 Jul 9. doi: 10.1038/s41591-026-04538-9. Online ahead of print. PMID 42426224

Идентификаторы

NCT: NCT06520488 · HRS-4642-202

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗