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

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.

Study Overview

• Status: Recruiting
• Conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: SHR-A1811 and SHR-1701; Drug: SHR-A1811 and capecitabine; Drug: SHR-A1811 and capecitabine; Drug: SHR-A181, SHR-1701, and capecitabine; Drug: SHR-A1811, SHR-1316, and capecitabine; Drug: SHR-A1811, SHR-1316, and capecitabine; Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin; Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin; Drug: SHR-A1811, SHR-1316, and 5-FU; Drug: SHR-A1811, SHR-1316, and 5-FU; Drug: SHR-1316 and SHR-A1811; Drug: SHR-A1811and 5-FU

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiwei Sun; Phone Number: +86 18036618554; Email: Shiwei.sun@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Tianshu Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1A: SHR-A1811 and SHR-1701	Drug: SHR-A1811 and SHR-1701; (Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;
Experimental: Arm 1B: SHR-A1811 and capecitabine	Drug: SHR-A1811 and capecitabine; (Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； Drug: SHR-A1811 and capecitabine; (Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
Experimental: Arm 1C: SHR-A181, SHR-1701, and capecitabine	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；
Experimental: Arm 1D: SHR-A1811, SHR-1316, and capecitabine	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, and capecitabine; (Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；
Experimental: Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	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, 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
Experimental: Arm 1G: SHR-A1811, SHR-1316, and 5-FU	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 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
Experimental: Arm 2A: SHR-A1811, SHR-1316, and capecitabine	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, and capecitabine; (Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；
Experimental: Arm 2B: SHR-1316 and SHR-A181	Drug: SHR-1316 and SHR-A1811; (Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion
Experimental: Arm 2C: SHR-A1811 and capecitabine	Drug: SHR-A1811 and capecitabine; (Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； Drug: SHR-A1811 and capecitabine; (Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；
Experimental: Arm 2D: SHR-A1811, SHR-1316, and 5-FU	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 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
Experimental: Arm 2E: SHR-A1811and 5-FU	Drug: SHR-A1811and 5-FU; (Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion
Experimental: Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	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, 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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]

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Stomach Neoplasms; Esophageal Neoplasms; Adenocarcinoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Capecitabine; Fluorouracil; SHR-1701
• Other Study ID Numbers: SHR-A1811-Ib/II-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No