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 who are willing and able to provide written consent before any trial activities begin
• Men and women aged 19 years or older
• People who have been confirmed through tissue or cell testing to have stomach or gastroesophageal junction (the area where the stomach meets the food pipe) cancer that has spread or cannot be surgically removed, and whose cancer tests at a specific low level of a protein called HER2 (either 1+ on one test, or 2+ on one test but without gene amplification on a second test)
• People whose cancer got worse after one round of treatment aimed at controlling (not curing) the cancer — including cases where cancer came back within 6 months of finishing chemotherapy given after surgery
• People whose cancer can be measured or assessed on scans using standard criteria (RECIST version 1.1)
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1)
• People expected to live for at least 12 weeks, as judged by the treating doctor
• People whose heart is pumping blood at 50% efficiency or above, confirmed by a heart scan done within 28 days before joining
• People whose blood test results for immune cells, platelets, red blood cells, liver function, kidney function, protein levels, urine protein, and blood clotting are all within acceptable ranges as defined by the trial
• People who have waited long enough after previous treatments before joining — at least 4 weeks after major surgery or radiation therapy, and at least 3 weeks after certain anti-cancer or immunotherapy treatments
• Women who have gone through menopause, or women of childbearing potential who test negative for pregnancy before joining
• Women of childbearing potential who are sexually active with a male partner who has not had a sterilisation procedure must use at least one highly effective form of contraception from screening and for 7 months after the last dose of the trial medication
• Men who have not had a sterilisation procedure and are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening until 4 months after the last dose of trial medication
• Women must agree not to donate or store eggs from the time of joining until at least 7 months after the last dose of trial medication

Who may not be able to join:

• People who have received any anti-cancer treatment within 14 days before starting the trial
• People who have had major surgery within 28 days before starting the trial
• People who have already received more than two rounds of chemotherapy for this cancer
• People who have moderate or severe nerve damage in their hands or feet (Grade 2 or higher peripheral neuropathy)
• People who have been diagnosed with more than one type of cancer within the past 3 years
• People with a history of heart attack within the past 6 months, significant heart failure, unstable chest pain (angina), serious irregular heart rhythms, or a stroke or other major heart or blood vessel event within the past 6 months
• People whose heart's electrical activity shows a specific timing measurement (QTc interval) that is too long — above 470 milliseconds for women or 450 milliseconds for men — on a heart tracing (ECG)
• People who have had a tear or hole in the gut, an abnormal channel (fistula) in the gut, serious bleeding, or a blood clot in an artery or vein within 3 months before starting treatment
• People who have a history of lung inflammation (not caused by infection) that needed steroid treatment, or who currently have lung inflammation, or where lung inflammation cannot be ruled out by scans
• People with existing significant lung conditions, certain immune or inflammatory disorders affecting connective tissue, or who have had a full lung removed
• People with active cancer that has spread to the brain or the lining around the brain and spine
• People with substance use issues or other significant medical or psychological conditions that the doctor believes could interfere with participation or results
• People with cancer pressing on the spinal cord, or brain or spinal metastases that are untreated, causing symptoms, or requiring steroid or seizure medication to manage
• People with an active, uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungal medicines
• People with a known immune deficiency condition, uncontrolled HIV, or active hepatitis B or C infection (note: people with a past hepatitis C infection may be eligible if a specific virus test comes back negative — confirm with trial site)
• People who have received a live or weakened vaccine within 30 days before the first dose of the trial drug (certain COVID-19 vaccines are not considered live vaccines — confirm with trial site)
• People who still have side effects from previous cancer treatments that have not resolved to mild or baseline levels (hair loss is an exception)
• People with a known allergy or sensitivity to the trial drug or any of its ingredients
• People with a history of severe allergic reactions to similar antibody-based medicines
• Women who are pregnant, breastfeeding, or planning to become pregnant
• People whom the trial doctor considers otherwise unsuitable for the study for any reason
• People with moderate-to-severe liver scarring (cirrhosis rated Child-Pugh B or worse), or any level of cirrhosis combined with a history of brain confusion caused by liver disease, or significant fluid buildup in the abdomen from cirrhosis that has required medication or drainage
• People with a serious or non-healing wound, ulcer, or bone fracture within 28 days before the first dose
• People currently taking certain blood-thinning medications such as dipyridamole or clopidogrel on an ongoing basis (low-dose daily aspirin up to 325 mg per day is allowed)
• People with high blood pressure that is not well controlled (above 160/100 mmHg for more than 4 weeks) despite standard treatment

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