Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from 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 (any gender)
• People in a specific group (Cohort 1, Phase II) who have been diagnosed with advanced or spread-out stomach cancer (including cancer at the junction of the stomach and food pipe) confirmed by a tissue test, where surgery or local treatment is not suitable, and who have not previously received systemic cancer treatments — or who received chemotherapy more than 6 months ago and whose cancer has since come back or grown; and whose cancer tests show high levels of a protein called HER2 (confirmed by specific lab tests)
• People in another specific group (Cohort 2, Phase II) who have advanced solid tumour cancers confirmed by tissue or cell testing, where standard treatments have failed or are not available, and whose tumours show low-but-present HER2 levels on lab testing
• People in another group (Cohort 3, Phase II) who have advanced or spread-out stomach cancer (including stomach-food pipe junction cancer) or bowel cancer confirmed by tissue testing, where surgery or local treatment is not suitable, who have not previously received systemic cancer treatments (or received chemotherapy more than 6 months ago with evidence the cancer has since grown); bowel cancer patients must also have certain gene types (wild-type KRAS, NRAS, and BRAF); and all must show low HER2 levels on specific lab tests
• People in Phase III who have locally advanced or spread-out stomach cancer (including stomach-food pipe junction cancer) confirmed by tissue testing, who have not received prior systemic cancer treatment for stomach cancer (one short course of a specific chemotherapy is permitted), or who finished earlier chemotherapy at least 6 months ago with evidence the cancer has since progressed; HER2 positivity must be confirmed by lab tests; and a specific immune marker on tumour tissue (PD-L1 CPS score) must be less than 1
• People who have at least one tumour that can be measured using standard imaging methods (confirm with trial site for tumours previously treated with radiation)
• People who are reasonably physically active and able to care for themselves, scored 0 or 1 on a standard physical fitness scale used in cancer trials
• People with an expected survival of at least 3 months
• People whose blood counts, liver, kidney, and clotting function meet specific levels shown in blood tests (confirm with trial site for exact values)
• People of childbearing potential who agree to use reliable contraception throughout the trial and for at least 6 months after the last dose; women of childbearing potential must have a negative pregnancy blood test within 7 days before starting the study drug
• People who have read, understood, and signed a written consent form before joining the trial

Who may not be able to join:

• People in Cohort 2 (Phase II) who received cancer treatments such as chemotherapy, radiation, immunotherapy, or similar therapies within 4 weeks before the first study dose (with some exceptions for certain drug types — confirm with trial site)
• People who took part in another clinical trial or received an unlisted experimental treatment within 4 weeks before the first study dose
• People who still have significant side effects from previous cancer treatments that have not sufficiently improved (with some exceptions such as hair loss or stable thyroid issues)
• People with a known serious allergic reaction to any antibody-based medicine, or to any ingredient in the study drug or the chemotherapy combination used in this trial
• People whose tumours have been diagnosed with a specific genetic feature called dMMR or MSI-H (high microsatellite instability)
• People who had major surgery or a serious injury within 4 weeks before the first study dose, or who need planned surgery during the trial
• People who have taken high-dose steroid tablets or injections (above a certain level) within 14 days before the first study dose, with some exceptions for topical, inhaled, or short-term preventive steroids
• People who have taken other immune-suppressing medicines within 28 days (or 5 half-lives, whichever is longer) before the first study dose
• People who have taken immune-modifying medicines within 14 days before the first study dose
• People who received a live vaccine within 4 weeks before the first study dose
• People who have previously had a bone marrow or organ transplant from another person
• People with active, symptom-causing cancer spread to the brain or the lining around the brain
• People who currently have an active infection requiring intravenous (IV) antibiotics or antiviral medicines
• People with a known weakened immune system, including those who test positive for HIV
• People with active hepatitis B or active hepatitis C confirmed by specific blood tests
• People with severe and uncontrolled lung disease (such as serious lung infection or scarring of the lung tissue)
• People with a history of serious heart problems, including dangerous heart rhythm problems, significant heart blockages, recent heart attack, heart failure, stroke or other major heart events within the past 6 months, poor heart pumping function, or uncontrolled high blood pressure
• People with an active autoimmune disease (where the immune system attacks the body) or one that could come back, with some exceptions for stable conditions such as controlled thyroid disease, type 1 diabetes, or vitiligo
• People who have had another cancer within the past 5 years, except for certain cancers that are considered fully treated and cured (such as early-stage skin cancers or certain in-situ cancers — confirm with trial site)
• People with large fluid build-ups in body cavities that the treating doctor considers uncontrolled and a reason not to participate
• People with a known dependence on alcohol or drugs
• People with a mental health condition or who are unlikely to be able to follow the trial requirements
• Women who are pregnant or breastfeeding
• People who, in the opinion of the trial doctor, have other serious health conditions that make participation unsuitable

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