NCT05671822RecruitingPhase 2
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 14 Mar 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05671822
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 258
- From 14 Mar 2023 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery was performed within 4 weeks;
- There was severe infection within 4 weeks before starting the study treatment;
- Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
Other illness
- Have active autoimmune disease or history of autoimmune disease;
- Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
- Serious cardiovascular and cerebrovascular diseases;
Other
- There were ascites, pleural effusion and pericardial effusion that needed to be treated;
- Patients with interstitial pneumonia;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.