A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer

Официальное название

A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment

Обзор

This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.

Вмешательства

• Препарат SHR-A1811 Injection
  SHR-A1811 for injection.

Первичные конечные точки

• Objective response rate (ORR) assessed by Independent Review Committee (IRC) [Срок оценки: Up to 2 years.]

Вторичные конечные точки (11)

• Overall survival (OS) assessed by Independent Review Committee (IRC) [Срок оценки: Up to 2 years.]
• Overall survival (OS) assessed by investigators [Срок оценки: Up to 2 years.]
• Progression free survival (PFS) assessed by Independent Review Committee (IRC) [Срок оценки: Up to 2 years.]
• Progression free survival (PFS) assessed by investigators [Срок оценки: Up to 2 years.]
• Duration of response (DoR) assessed by Independent Review Committee (IRC) [Срок оценки: Up to 2 years.]
• Duration of response (DoR) assessed by investigators [Срок оценки: Up to 2 years.]
• Disease control rate (DCR) assessed by Independent Review Committee (IRC) [Срок оценки: Up to 2 years.]
• Disease control rate (DCR) assessed by investigators [Срок оценки: Up to 2 years.]
• Objective response rate (ORR) assessed by investigators [Срок оценки: Up to 2 years.]
• Adverse events (AEs) [Срок оценки: Up to 2 years.]
• Serious adverse events (SAEs) [Срок оценки: Up to 2 years.]

Критерии участия

Критерии включения

• Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
• Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
• Cervical cancer confirmed by tissue or cytological pathology.
• Expected survival ≥ 12 weeks.
• Normal function of important organs.
• Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.

Критерии исключения

• Subjects with known untreated or active central nervous system (CNS) tumor metastases.
• Subjects with other malignant tumors in the past or at the same time.
• Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
• Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
• Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
• Subjects with known lung damage caused by concurrent lung diseases.
• Subjects with active pulmonary tuberculosis.
• Subjects with poorly controlled or severe cardiovascular diseases.
• Subjects with arterial/venous thrombotic events within 1 month before enrollment.
• Subjects who had a serious infection within 1 month before enrollment.
• History of immunodeficiency, including positive HIV test.

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 · 2 центра

• Fujian Cancer Hospital — Фучжоу
• Shandong University Qilu Hospital — Цзинань

Идентификаторы

NCT: NCT07051486 · SHR-A1811-218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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