Combining SHR-A1811 with chemo and immunotherapy for advanced HER2-expressing stomach and gastroesophageal junction cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase Ib/II trial will explore safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with various chemotherapy and immunotherapy agents in patients with advanced or metastatic HER2-expressing gastric or gastroesophageal junction adenocarcinoma. Phase Ib enrolls patients who are either treatment-naïve or have failed or are intolerant to prior standard therapy to establish safe combination regimens. Phase II expands selected combinations to previously untreated patients to measure efficacy and continued safety. Combination partners include agents such as SHR-1701, SHR-1316, capecitabine, and oxaliplatin across multiple cohorts.

Why it matters

Who can join: the full rules

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 ≥3 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;

Where it's running

• Zhongshan Hospital, FuDan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shiwei Sun
• Email: Shiwei.sun@hengrui.com
• Phone: +86 18036618554

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.