Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Recruiting now · Phase 2
Conditions studied: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT05671822
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 258
- Starts
- 2023-03-14
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Zhongshan Hospital, FuDan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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