HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Conditions
Brief 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.
Interventions
DRUGSHR-A1811 and SHR-1701
(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
DRUGSHR-A1811 and capecitabine
(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
DRUGSHR-A181, SHR-1701, and capecitabine
(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；
DRUGSHR-A1811, SHR-1316, and capecitabine
(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；
DRUGSHR-A1811, SHR-1316, capecitabine,and oxaliplatin
(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion
DRUGSHR-A1811, SHR-1316, and 5-FU
(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion
DRUGSHR-1316 and SHR-A1811
(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
DRUGSHR-A1811and 5-FU
(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 18 to 75, Male and female participants 2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; 3. HER2 expression ; 4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients; 5. ECOG 0-1; 6. The expected survival ≥3 months; 7. Sufficient bone marrow and organ functions;
Exclusion criteria
1. There were ascites, pleural effusion and pericardial effusion that needed to be treated; 2. Major surgery was performed within 4 weeks; 3. Have active autoimmune disease or history of autoimmune disease; 4. Patients with interstitial pneumonia; 5. There was severe infection within 4 weeks before starting the study treatment; 6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; 7. Serious cardiovascular and cerebrovascular diseases; 8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) | Safety will be assessed for approximately 24 months from informed consent |
| Phase II: Objective Response Rate (ORR)[ | An average of approximately 12 months |
Secondary
| Measure | Time frame |
|---|---|
| ORR（Phase Ib） | An average of approximately 12 months |
| DoR（Phase Ib） | An average of approximately 18 months |
| PFS（Phase Ib） | An average of approximately 18 months |
| OS（Phase Ib） | An average of approximately 30 months |
| DoR（Phase II） | An average of approximately 18 months |
| PFS（Phase II） | An average of approximately 18 months |
| OS（Phase II） | An average of approximately 30 months |
| Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II） | Safety will be assessed for approximately 24 months from informed consent] |
Countries
China
Contacts
CONTACTShiwei Sun
Outcome results
None listed