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Tests treatment safety and results for HER2 Expression Gastric Cancer/Gastroesophageal Junction...
Official title Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
ClinicalTrials.gov ID: NCT05671822
What this study is testing
What is SHR-A1811 and SHR-1701?
SHR-A1811 and SHR-1701 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2 expression gastric cancer/gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- ECOG 0-1;
You likely can't join 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;
See the full eligibility criteria
- 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;
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.