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 who have been diagnosed with stomach (gastric) or gastroesophageal junction (GEJ) cancer that has been confirmed by tissue testing (biopsy).
• People whose cancer has been confirmed by imaging scans to be advanced, unable to be removed by surgery, or has spread to other parts of the body — confirmed within 28 days before joining the trial.
• People whose cancer can be measured or tracked on imaging scans according to standard criteria, assessed within 28 days before joining the trial (confirm with trial site for specific requirements if prior radiation therapy was involved).
• People who are generally well enough to carry out light activity and care for themselves, as assessed using a standard health performance scale (ECOG score of 0 or 1).
• People with a life expectancy of at least 12 weeks.
• People whose cancer is suitable for treatment with specific chemotherapy combinations (mFOLFOX6 or CAPOX) and the immunotherapy drug pembrolizumab, as determined by their treating doctor.
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or have had a negative pregnancy test at screening — and who agree to use reliable contraception and not donate eggs for a specified period after treatment ends.
• Men who agree to use contraception with partners who could become pregnant, remain abstinent or use a condom with pregnant partners, and not donate sperm during treatment and for 6 months after the final study treatment.
• People whose tumour has tested negative for a protein called HER2.
• People whose tumour shows a high level of a protein called Claudin18.2 (CLDN18.2), confirmed by central laboratory testing.
• People whose tumour has a PD-L1 combined positive score (CPS) of 1 or higher, confirmed by central laboratory testing.
• People with a tumour type known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as long as the PD-L1 positivity requirement is also met.
• People whose recent blood test results (taken within 14 days before joining) meet specific laboratory criteria set by the trial (confirm exact values with trial site).
• People who agree not to participate in another interventional clinical trial at the same time as this one.

Who may not be able to join:

• People who have had a serious allergic reaction or intolerance to zolbetuximab, other monoclonal antibody drugs, pembrolizumab, or the chemotherapy combinations used in this trial (mFOLFOX6 or CAPOX).
• People who have a complete or partial blockage of the stomach outlet causing ongoing repeated vomiting.
• People who have significant stomach bleeding or untreated stomach ulcers that would make participation unsafe.
• People who have ongoing lung inflammation (pneumonitis) or a history of non-infectious lung inflammation, such as that caused by immune reactions or radiation.
• People who have had cancer spread to the brain or the lining around the brain from their gastric or GEJ cancer.
• People with a known positive HIV test, active hepatitis B infection, or active hepatitis C infection (certain exceptions apply — confirm with trial site).
• People with an active infection requiring treatment with antibiotics or other systemic medicines that has not fully resolved within 7 days before joining the trial.
• People with an active autoimmune disease that has required systemic medical treatment within the past 3 months (people with stable autoimmune disease on low-dose replacement steroid therapy may still be considered — confirm with trial site).
• People with a serious medical condition or other health problem that could make it unsafe to receive the trial treatments or make participation unsuitable.
• People who currently have another cancer that requires active treatment.
• People with a known complete deficiency of an enzyme called DPD (Dihydropyrimidine Dehydrogenase), which affects how certain chemotherapy drugs are processed by the body.
• People with known nerve damage in the hands or feet (peripheral neuropathy) that is worse than mild (grade 1), with an exception for loss of deep tendon reflexes alone.
• People with a liver condition called sinusoidal obstruction syndrome (also known as veno-occlusive disease) that is not stable or improving.
• People with significant heart conditions, including severe heart failure, heart attack, unstable chest pain, certain heart procedures, stroke, or hypertensive crisis within the past 6 months; certain irregular heart rhythms; a prolonged electrical interval in the heart (QTc) above specified limits; or a personal or family history of a condition called congenital long QT syndrome (confirm specific values and details with trial site).
• People with ongoing or previous interstitial lung disease, active inflammation of the colon (diverticulitis), active peptic ulcer disease, or a history of organ or stem cell transplant.
• People with type 1 diabetes (note: certain other hormonal or skin conditions that are stable and well-managed may still be permitted — confirm with trial site).
• People who have already received chemotherapy or immunotherapy for their advanced or metastatic stomach/GEJ cancer, with limited exceptions (confirm with trial site, as one prior short course of certain chemotherapy with or without pembrolizumab may be allowed under specific conditions).
• People who have received strong immune-suppressing medicines, including steroid tablets or injections, within 14 days before joining (low-dose replacement steroids or single-dose use may be permitted — confirm with trial site).
• People who have had a major surgical procedure within 28 days before joining, or who have not fully recovered from surgery within 14 days before joining.
• People who have received radiation therapy to their advanced stomach or GEJ cancer within 14 days before joining and have not yet recovered from any side effects.
• People who have previously been treated with any drug that targets the Claudin18.2 (CLDN18.2) protein.
• People who have received a live or live-attenuated vaccine (such as certain flu or travel vaccines) within 30 days before the first dose of trial treatment.
• People who have taken part in another clinical trial or received an experimental treatment within 28 days before joining, or within 5 half-lives of the experimental drug (whichever is longer).
• People with any other condition that the trial team determines makes participation unsuitable or unsafe.
• People who have taken the antiviral medicines brivudine, sorivudine, or chemically similar drugs within 28 days before joining (or within 5 half-lives of the drug, whichever is shorter).
• People with pernicious anaemia or other forms of anaemia caused by vitamin B12 deficiency.
• People with a known positive test for tuberculosis or a known active tuberculosis infection.

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