Phase 2 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 19 or older
• People with a life expectancy of at least 12 weeks
• People weighing more than 30 kg (or more than 35 kg for one specific treatment arm)
• People who have been diagnosed with a specific type of stomach or stomach-esophagus junction cancer (adenocarcinoma), with HER2 test results available from a tissue sample
• People whose cancer tests show either HER2-positive results (for certain study groups) or a protein called CLDN18.2-positive results (for other study groups)
• People whose cancer is locally advanced and cannot be removed by surgery, with no sign of cancer spreading to distant organs
• People whose general health and ability to carry out daily activities meets a specific fitness standard (ECOG score of 0 or 1), which must remain stable from the screening visit to the first treatment
• People whose heart pumping function (LVEF) is at least 50%, confirmed by a heart scan done within 28 days before treatment
• People who have measurable cancer that can be assessed by scans before surgery
• People whose blood counts, liver function, kidney function, and blood clotting levels fall within acceptable ranges on tests done within 14 days before treatment — specifically:
  • Haemoglobin (red blood cell level) of at least 9.0 g/dL
  • Platelet count of at least 100 x 10⁹/L
  • Neutrophil count (a type of white blood cell) of at least 1.5 x 10⁹/L
  • Bilirubin (liver waste product) within acceptable limits for liver health
  • Liver enzyme levels (AST and ALT) within acceptable limits
  • Blood protein (albumin) of at least 3.0 g/dL
  • Kidney function meeting minimum levels (exact threshold depends on which treatment arm applies)
  • Blood clotting measures within acceptable limits
• Female participants who are not pregnant, not breastfeeding, and who either are post-menopausal, have had certain sterilisation procedures, or are willing and able to use highly effective contraception during the trial and for a set period afterward
• Male participants who are not surgically sterilised and who are willing to use a condom with spermicide (or practise complete abstinence in line with their usual lifestyle) from the screening period through to a set period after the final dose

Who may not be able to join:

• People whose cancer has visibly spread to the lining of the abdomen (peritoneum) or to distant organs
• People with a known deficiency of an enzyme called DPD (dihydropyrimidine dehydrogenase), which affects how certain chemotherapy medicines are broken down
• People with cancer spread to the brain, or with certain nervous system conditions such as epilepsy, stroke within the past 3 months, severe brain injury, dementia, Parkinson's disease, or uncontrolled serious mental illness
• People with uncontrolled ongoing illness such as active serious infection, uncontrolled high blood pressure, serious ongoing stomach or bowel problems, active ulcers or gastrointestinal bleeding, or mental health or personal circumstances that would make it difficult to follow study requirements
• People who still have unresolved side effects from previous treatments — particularly nerve damage affecting sensation or movement at a moderate or severe level (Grade 2 or higher)
• People with a history of organ transplant
• People with active immune system deficiency disorders, active infectious diseases, or active or recent autoimmune or inflammatory conditions (such as Crohn's disease, ulcerative colitis, lupus, rheumatoid arthritis, tuberculosis, or others) that have required immune-suppressing treatment within the past 2 years — though some exceptions may apply (confirm with trial site)
• People with a history of drug-caused lung inflammation (ILD/pneumonitis) requiring steroid treatment, or current suspected lung inflammation that cannot be ruled out on scans
• People with active hepatitis B or active hepatitis C infection — though people with a past resolved infection may be considered if certain conditions are met (confirm with trial site)
• People with HIV infection that is not well controlled — well-controlled HIV may be considered if specific criteria are met (confirm with trial site)
• People with active tuberculosis
• People with certain heart conditions, including:
  • Abnormal heart rhythm measurements on an ECG above a specific threshold
  • Certain significant heart rhythm or conduction problems on a resting ECG
  • Conditions that increase the risk of abnormal heart rhythm, such as heart failure or a family history of a specific heart rhythm disorder
  • Uncontrolled low blood pressure
  • A fast irregular heart rhythm called atrial fibrillation with a resting heart rate above 100 beats per minute
  • Symptomatic heart failure
  • Known reduced heart pumping function below 55%
  • Any past or current disease affecting the heart muscle
  • Heart attack within the past 6 months
  • Severe heart valve disease
  • Uncontrolled chest pain (angina)
  • Stroke or mini-stroke before the screening period
  • Acute coronary syndrome within the past 6 months
• Female participants who are pregnant or breastfeeding, or any participant of reproductive potential who is not willing to use effective contraception as required
• People who have received another experimental drug or taken part in another clinical trial within the past 28 days (or within 5 half-lives of that drug, whichever is shorter)
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have used immune-suppressing medications within 14 days before the first treatment dose — with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm with trial site)
• People who have received a live vaccine within 30 days before the first study treatment dose
• For one specific treatment arm (Rilvegostomig): people with serious ongoing bowel conditions causing diarrhoea, active skin conditions requiring systemic treatment, or autoimmune/inflammatory conditions requiring ongoing steroid or immune-suppressing treatment
• For another specific treatment arm (Sone-Ve): people with a blood clot event (such as a deep vein thrombosis or pulmonary embolism) within the past 3 months, certain recent heart events, or elevated blood clot risk markers
• For the Sone-Ve arm: people with uncontrolled high blood pressure (systolic at or above 160 mmHg and/or diastolic at or above 100 mmHg), or known significant corneal (eye surface) disease
• For the Sone-Ve arm: people who have had major surgery within 28 days before the first treatment dose
• For the Sone-Ve arm: people with uncontrolled diabetes or diabetic nerve damage within 3 months before joining the trial
• For the Sone-Ve arm: people with moderate or severe nerve damage (sensory or movement-related) at the time of screening

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