A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181

Официальное название

A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours

Обзор

An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.

Вмешательства

• Препарат Hemay181
  intravenous infusion，once every 3 weeks

Первичные конечные точки

• Efficacy indicators [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Вторичные конечные точки (1)

• Safety indicators [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Критерии участия

Критерии включения

• Subjects who voluntarily signed a written informed consent form before the start of the study;
• Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
• Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
• At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\].
• Subjects with ECOG PS score of 0-1;
• Subjects with expected survival more than 3 months;
• Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study;

Критерии исключения

• Women during pregnancy or breastfeeding;
• HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;
• Having received drug treatment from another clinical trial within the four weeks prior to enrolment;
• Aallergy to the active ingredient or excipients of the investigational medicinal product;
• Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
• The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.

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

• Xinxiang Medical University First Affiliated Hospital — Xinxiang

Идентификаторы

NCT: NCT07446816 · HM181ST1S02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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