Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old, of any gender
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by a tissue or cell sample, that cannot be surgically removed and has either spread locally or to other parts of the body
• People who have previously received treatment that included a HER2-targeted therapy
• People whose cancer got worse during or after first-line (initial) standard treatment — prior treatment before or after surgery may also count if the cancer returned within 6 months of finishing it
• People whose tumour has been centrally tested and confirmed to be HER2-positive by specific laboratory methods (IHC 3+, or IHC 2+ with additional gene amplification testing)
• People who have at least one measurable area of cancer according to standard imaging measurement guidelines (RECIST 1.1)
• People with a physical functioning score of 0 or 1 on the ECOG scale, meaning fully active or restricted in strenuous activity only (confirm with trial site)
• People with an expected survival of at least 12 weeks
• People with adequate blood counts and healthy liver, kidney, and blood-clotting function
• People who are willing to give informed consent to participate in the study

Who may not be able to join:

• People who received any anti-cancer treatment (including chemotherapy, radiation, biological, targeted, or immunotherapy) within 4 weeks before the first trial dose
• People with known allergies to monoclonal antibodies or the inactive ingredients in the study drug, and who are also allergic to paclitaxel, docetaxel, and irinotecan
• People who still have side effects from previous cancer treatment that have not recovered to a mild level (Grade 1 or below on a standard medical grading scale)
• People who have active cancer spread to the brain or central nervous system that is currently causing symptoms
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires repeated draining
• People with significant digestive or gastrointestinal problems, as assessed by the study doctor
• People with a history of immune system deficiency, including a positive HIV test
• People who have unexplained fever above 38.5°C, a serious active infection, or signs of active lung inflammation detected during screening
• People who have interstitial lung disease (scarring or inflammation of the lungs), or who experienced severe interstitial lung disease (Grade 3 or higher) during prior immunotherapy treatment
• People with active hepatitis B (with viral levels above a specified threshold) or active hepatitis C (with detectable virus in the blood)
• People with significant heart or cardiovascular conditions, including severe chest pain, heart failure, serious heart rhythm problems, a heart attack within the past 6 months, a stroke or mini-stroke, an abnormal heart electrical reading (QTcF of 470 ms or more), reduced heart pumping function (ejection fraction below 50%), or uncontrolled high blood pressure
• People who have had another cancer within the past 5 years
• People who are pregnant or breastfeeding
• People who, in the study doctor's opinion, have other factors that may make it unsuitable for them to continue in the study

Important: Always verify eligibility with the trial site directly before applying.