Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gas… (NCT05671822) | Clinical Trial Compass
RecruitingPhase 2
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
China258 participantsStarted 2023-03-14
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)
Timeframe: Safety will be assessed for approximately 24 months from informed consent