Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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.
Official title: A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
258
Start Date
2023-03-14
Completion Date
2027-12
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
SHR-A1811 and SHR-1701
(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
SHR-A1811 and capecitabine
(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-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；
SHR-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；
SHR-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
SHR-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
SHR-A1811, SHR-1316, and capecitabine
(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；
SHR-1316 and SHR-A1811
(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
SHR-A1811 and capecitabine
(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
SHR-A1811, SHR-1316, and 5-FU
(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion
SHR-A1811and 5-FU
(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion
SHR-A1811, SHR-1316, capecitabine,and oxaliplatin
(Arm 2F) 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
Locations (1)
Zhongshan Hospital, FuDan University
Shanghai, Shanghai Municipality, China