Recruiting

SHR-A1811 Combinations for Advanced/Metastatic HER2 Expression Gastric/Gastroesophageal Junction Adenocarcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and effectiveness of SHR-A1811 combinations in treating advanced or metastatic gastric/gastroesophageal junction adenocarcinoma with HER2 expression, by observing the rates of dose limiting toxicity, occurrence of adverse events, and measuring the objective response rate.

What is being tested

SHR-A1811 and SHR-1701

+ SHR-A1811 and capecitabine

+ SHR-A181, SHR-1701, and capecitabine

Drug
Who is being recruted

From 18 to 75 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ContactShiwei Sun
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 14, 2023

Actual date on which the first participant was enrolled.

This study focuses on a treatment for advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, a type of cancer that affects the stomach and the area where the stomach joins the esophagus. The treatment being studied is SHR-A1811, which is used in combination with chemotherapy and/or immunotherapy. The main goal of this study is to evaluate the safety and effectiveness of this treatment for patients whose cancer expresses a protein called HER2. The study is important as it aims to provide a new treatment option for patients with this type of cancer, potentially improving their care and quality of life. The study consists of two parts, Phase Ib and Phase II. In Phase Ib, the study measures the safety, tolerability, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy. This is done by evaluating the rates of dose limiting toxicity, occurrence of adverse events, and serious adverse events. In Phase II, the study evaluates the efficacy and safety of the same treatment combination. This is measured by the objective response rate, which is the percentage of patients whose cancer shrinks or disappears after treatment.

Official TitleA Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
NCT05671822
Principal SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ContactShiwei Sun
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

258 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
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;

Show More Criteria

8 exclusion criteria prevent from participating
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;

Patients with interstitial pneumonia;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

12 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Group 6

Experimental

Group 7

Experimental

Group 8

Experimental

Group 9

Experimental

Group 10

Experimental

Group 11

Experimental

Group 12

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Zhongshan Hospital, FuDan University

Shanghai, ChinaOpen Zhongshan Hospital, FuDan University in Google Maps
Recruiting
One Study Center