Actively Recruiting
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-02-12
258
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75, male and female participants
- Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology
- HER2 expression present
- Phase Ib: Failed or intolerant to prior standard treatment or no prior systemic anti-tumor therapy; Phase II: previously untreated patients
- ECOG performance status of 0 to 1
- Expected survival of at least 3 months
- Adequate bone marrow and organ function
You will not qualify if you...
- Presence of ascites, pleural effusion, or pericardial effusion requiring treatment
- Major surgery within 4 weeks before study entry
- Active or history of autoimmune disease
- Diagnosis of interstitial pneumonia
- Severe infection within 4 weeks before starting study treatment
- Active pulmonary tuberculosis infection within 1 year before enrollment
- Serious cardiovascular or cerebrovascular diseases
- Gastrointestinal perforation or fistula within 6 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, FuDan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Shiwei Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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