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 who have voluntarily agreed to take part and have signed a consent form
• People aged between 18 and 75 years old (inclusive)
• People whose doctors expect them to live for at least 12 weeks
• People with a good general physical functioning level, rated 0 or 1 on a standard medical scale (ECOG score)
• People who have been confirmed by tissue or cell testing to have locally advanced or metastatic stomach cancer, including cancer at the junction where the stomach meets the oesophagus
• People whose cancer has stopped responding to, or who could not tolerate, one prior standard first-line treatment (not including paclitaxel); prior treatment with certain immune checkpoint drugs (PD-1/PD-L1 inhibitors) is allowed
• People whose tumour tissue has been tested and shows certain levels of HER2 protein (scored 1+, 2+, or 3+) and a protein called PD-L1 — testing requirements differ depending on which phase of the trial a person is enrolled in (confirm with trial site)
• People whose blood counts meet minimum levels: haemoglobin at least 9 g/dL, neutrophil count at least 1.5 × 10⁹/L, and platelet count at least 90 × 10⁹/L, without recent blood transfusions or certain blood-boosting treatments in the prior 2 weeks
• People whose liver function blood test results are within acceptable ranges, with slightly higher limits allowed if cancer has spread to the liver
• People whose kidney function is within acceptable ranges, based on blood or urine tests
• People whose blood clotting test results are within acceptable ranges
• People whose heart is functioning well enough, with a heart pumping strength (ejection fraction) of at least 50% and a heart failure rating below class 3
• People who can provide at least 5 tumour tissue samples collected within the past 3 years, preferably taken after first-line treatment stopped working
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• Female participants who are surgically sterilised, post-menopausal, or willing to use an approved form of contraception during the study and for 6 months after treatment ends; who have had a negative blood pregnancy test within 7 days before starting the study drug; who are not breastfeeding; and who agree not to donate eggs from consent until 6 months after the last dose
• Male participants who are surgically sterilised or willing to use an approved form of contraception during the study and for 6 months after treatment ends, and who agree not to donate sperm from consent until at least 4 months after the last dose
• People who are able to understand what the trial involves and are willing and able to follow the trial procedures and follow-up visits

Who may not be able to join:

• People whose cancer has spread to the brain or the lining around the brain or spinal cord
• People who have previously been treated with any antibody-drug conjugate (a specific type of cancer drug), including Disitamab Vedotin, or with a drug called cardinolizumab
• People who still have side effects from previous cancer treatment that have not improved to a mild level (Grade 1 or lower on a standard scale), with the exception of hair loss, skin darkening, or other conditions the doctor determines do not increase the risk of harm
• People who received intensive (radical) radiotherapy within 3 months before starting the study drug; limited palliative radiotherapy within the prior 2 weeks may be permitted under certain conditions (confirm with trial site)
• People who had major surgery within 4 weeks before starting the study drug and have not fully recovered
• People who received a live vaccine within 28 days before the first study dose, or who plan to receive any vaccine during the study
• People who have a significant build-up of fluid in a body cavity (such as the chest or abdomen) that is causing symptoms or requires treatment
• People who have ongoing moderate-to-severe nerve damage affecting sensation or movement (Grade 2 or higher)
• People who test positive for active Hepatitis B virus, active Hepatitis C virus (unless a specific follow-up test is negative), or HIV
• People who have had a serious blood clot, stroke, heart attack, angina, or similar cardiovascular event in the 6 months before starting the study drug (certain minor, symptom-free conditions may be excepted — confirm with trial site)
• People whose tumour has a tendency to bleed, or who have had vomiting of blood or black stools in the 2 months before signing the consent form, or who received a blood transfusion within 4 weeks before starting the study drug
• People who have an active or worsening infection that requires ongoing systemic (whole-body) treatment
• People who have poorly controlled ongoing conditions such as diabetes, high blood pressure, liver cirrhosis, lung inflammation, or obstructive lung disease, as judged by their doctor
• People who have an active autoimmune disease that has required systemic treatment (such as immune-suppressing medications or steroids) within the past 2 years; certain hormone replacement therapies are excepted
• People who have had another cancer within the past 5 years, except for certain cancers considered to be effectively treated (such as some thyroid cancers, early-stage cervical changes, certain skin cancers, or breast ductal carcinoma in situ treated with surgery)
• People who have previously had a bone marrow transplant or an organ transplant from another person
• People who are known to be allergic to immune-suppressing drugs, antibody-drug conjugates, or any of the other drugs used in this trial
• Women who are pregnant or breastfeeding
• People who have any other medical condition, abnormal test result, or other factor that their doctor believes makes participation in this trial unsafe or unsuitable

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