SHR-A1811 Combinations for Advanced/Metastatic HER2 Expression Gastric/Gastroesophageal Junction Adenocarcinoma
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.
SHR-A1811 and SHR-1701
+ SHR-A1811 and capecitabine
+ SHR-A181, SHR-1701, and capecitabine
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.258 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.12 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
ExperimentalGroup 10
ExperimentalGroup 11
ExperimentalGroup 12
ExperimentalStudy 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
Zhongshan Hospital, FuDan University
Shanghai, ChinaOpen Zhongshan Hospital, FuDan University in Google Maps