A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

Официальное название

A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

Обзор

This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.

Вмешательства

• Препарат SHR-A1904 for Injection
  SHR-A1904 for injection, different doses.

Первичные конечные точки

• Objective response rate (ORR) assessed by investigator. [Срок оценки: Until progression, assessed up to approximately 1 year.]

Вторичные конечные точки (9)

• Disease control rate (DCR) assessed by investigator. [Срок оценки: Approximately 1 year.]
• Duration of objective tumor response (DoR) assessed by investigator. [Срок оценки: Approximately 1 year.]
• Time to response (TTR) assessed by investigator. [Срок оценки: Approximately 1 year.]
• Progression-free survival (PFS) assessed by investigator. [Срок оценки: Approximately 1 year.]
• Overall survival (OS). [Срок оценки: Approximately 2 years.]
• Adverse events (AEs). [Срок оценки: Until study completion, assessed up to approximately 1 year.]
• Serious adverse events (SAEs). [Срок оценки: Until study completion, assessed up to approximately 1 year.]
• Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA). [Срок оценки: Approximately 6 months.]
• Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb). [Срок оценки: Approximately 6 months.]

Критерии участия

Критерии включения

• Age 18-75 years old (including both ends), male or female;
• ECOG-PS score: 0 or 1;
• Expected survival ≥ 12 weeks;
• Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
• CLDN18.2 positive expression;
• Subjects who failed or intolerance after systemic chemotherapies;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
• The main organ function is normal, in line with the program requirements;
• Consent to contraception.

Критерии исключения

• Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
• Other active malignancies within 5 years or at the same time;
• Subjects with a history or evidence of brain metastasis or meningeal metastasis;
• With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
• Severe trauma or major surgery was performed within 4 weeks before the first administration;
• To study the severe heart disease within 6 months before the first administration;
• Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
• Severe infection symptoms occurred within 2 weeks before the first administration;
• Known hereditary or acquired bleeding and thrombotic tendency;
• Congenital or acquired immune defects;
• The subjects had severe and uncontrollable concomitant diseases;
• Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT07450976 · SHR-A1904-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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