NCT05671822

Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer

A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	SHR-A1811 and SHR-1701	(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
DRUG	SHR-A1811 and capecitabine	(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
DRUG	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；
DRUG	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；
DRUG	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
DRUG	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
DRUG	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；
DRUG	SHR-1316 and SHR-A1811	(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
DRUG	SHR-A1811 and capecitabine	(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
DRUG	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
DRUG	SHR-A1811and 5-FU	(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion
DRUG	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

Timeline

• Start date: 2023-03-14
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2023-01-05
• Last updated: 2026-02-12

Locations

1 site across 1 country: China