Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer

Официальное название

A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma

Обзор

This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.

Вмешательства

• Препарат SHR-A1811 and SHR-1701
  (Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
• Препарат SHR-A1811 and capecitabine
  (Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
• Препарат SHR-A181, SHR-1701, and capecitabine
  (Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；
• Препарат SHR-A1811, SHR-1316, and capecitabine
  (Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；
• Препарат SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
  (Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion
• Препарат SHR-A1811, SHR-1316, and 5-FU
  (Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion
• Препарат SHR-A1811, SHR-1316, and capecitabine
  (Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；
• Препарат SHR-1316 and SHR-A1811
  (Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
• Препарат SHR-A1811 and capecitabine
  (Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
• Препарат SHR-A1811, SHR-1316, and 5-FU
  (Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Первичные конечные точки

• Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) [Срок оценки: Safety will be assessed for approximately 24 months from informed consent]
• Phase II: Objective Response Rate (ORR)[ [Срок оценки: An average of approximately 12 months]

Вторичные конечные точки (8)

• ORR（Phase Ib） [Срок оценки: An average of approximately 12 months]
• DoR（Phase Ib） [Срок оценки: An average of approximately 18 months]
• PFS（Phase Ib） [Срок оценки: An average of approximately 18 months]
• OS（Phase Ib） [Срок оценки: An average of approximately 30 months]
• DoR（Phase II） [Срок оценки: An average of approximately 18 months]
• PFS（Phase II） [Срок оценки: An average of approximately 18 months]
• OS（Phase II） [Срок оценки: An average of approximately 30 months]
• Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II） [Срок оценки: Safety will be assessed for approximately 24 months from informed consent]]

Критерии участия

Критерии включения

• Age from 18 to 75, Male and female participants
• Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
• HER2 expression ;
• Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
• ECOG 0-1;
• The expected survival ≥3 months;
• Sufficient bone marrow and organ functions;

Критерии исключения

• There were ascites, pleural effusion and pericardial effusion that needed to be treated;
• Major surgery was performed within 4 weeks;
• Have active autoimmune disease or history of autoimmune disease;
• Patients with interstitial pneumonia;
• There was severe infection within 4 weeks before starting the study treatment;
• Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
• Serious cardiovascular and cerebrovascular diseases;
• Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;

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 · 1 центр

• Zhongshan Hospital, FuDan University — Шанхай

Идентификаторы

NCT: NCT05671822 · SHR-A1811-Ib/II-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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