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

RecruitingPhase 2Ages 18 Years - 75 YearsAllSuzhou Suncadia Biopharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age from 18 to 75, Male and female participants 2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; 3. HER2 expression ; 4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients; 5. ECOG 0-1; 6. The expected survival โ‰ฅ3 months; 7. Sufficient bone marrow and organ functions; Exclusion Criteria: 1. There were ascites, pleural effusion and pericardial effusion that needed to be treated; 2. Major surgery was performed within 4 weeks; 3. Have active autoimmune disease or history of autoimmune disease; 4. Patients with interstitial pneumonia; 5. There was severe infection within 4 weeks before starting the study treatment; 6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; 7. Serious cardiovascular and cerebrovascular diseases; 8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
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What it tests

  • SHR-A1811 and SHR-1701
  • SHR-A1811 and capecitabine
  • SHR-A181, SHR-1701, and capecitabine
  • SHR-A1811, SHR-1316, and capecitabine
  • SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
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Where

1 site
Zhongshan Hospital, FuDan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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