A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

Официальное название

A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.

Обзор

To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.

Вмешательства

• Препарат SPH5030
  SPH5030：Oral, QD, 600mg

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Approximately 2 years]

Вторичные конечные точки (5)

• Duration of remission (DOR) [Срок оценки: Approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Approximately 2 years]
• Progression-free survival (PFS) [Срок оценки: Approximately 2 years]
• Overall Survival (OS) [Срок оценки: Approximately 2 years]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
• HER2 positive or HER2 gene mutation;
• Meet the requirements of previous treatment;
• ECOG performance status of 0 or 1；
• Expected survival ≥ 3 months;
• No serious abnormalities in hematopoietic function, liver or kidney function;
• Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
• Fully informed subjects who voluntarily sign the ICF.

Критерии исключения

• Subjects who have previously received anti-HER2 molecular targeted therapy;
• Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
• Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;

5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.

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 · 30 центров

• Beijing Friendship Hospital，Capital Medical University — Пекин
• Chinese PLA General hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• The Second Affiliatedf Hospital of AFMU — Пекин
• XiangYa Hospital CentralSouth University — Чанша
• Changzhi People's Hospital — Changzhi
• Fujian Cancer Hospital — Фучжоу
• General Hospital of Fuzhou — Фучжоу
• … и ещё 22 центра

Идентификаторы

NCT: NCT06434597 · SPH5030-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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