Phase 2 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 19 years or older
• People who have been diagnosed with advanced or metastatic stomach cancer or cancer of the junction between the stomach and oesophagus (confirmed by a tissue test), with at least one tumour that can be measured on a scan
• People whose cancer tests show a specific low level of a protein called HER2 (described as HER2 1+, or HER2 2+ with a negative SISH test)
• People who are willing and able to follow the trial schedule, including attending all visits and receiving treatment as planned
• People who are generally well enough to carry out light activity and look after themselves, with a health status score of 0 or 1 on a standard medical scale, and whose health has not declined between the initial assessment and first treatment
• People who are expected to live for at least 3 months from the time of their first dose
• People who have waited the required amount of time since their last treatment before starting the trial — for example, at least 4 weeks after major surgery or certain cancer therapies, or at least 2 weeks after some other treatments (confirm specific waiting periods with the trial site)
• People whose blood test results for bone marrow, liver, and kidney function fall within acceptable ranges, tested within 28 days before starting treatment (confirm specific values with the trial site)
• Female patients who are not pregnant, not breastfeeding, and who agree to use reliable contraception during the trial and for 7 months after their last dose — or who meet criteria showing they cannot become pregnant (such as being post-menopausal or having had certain surgical procedures)
• Male patients who are not surgically sterilised and are sexually active with a female partner who could become pregnant must use a condom with spermicide from the start of the trial until 4 months after their last dose, and must not donate sperm during this period
• People who agree to have a tumour tissue sample (biopsy) taken before treatment starts and again if the cancer gets worse

Who may not be able to join:

• People who have had a heart attack within the past 6 months, or who have symptoms of heart failure, unstable chest pain, or a serious heart rhythm problem requiring treatment
• People who have had lung inflammation (a condition called ILD or pneumonitis) that needed steroid treatment, or who currently have this condition, or where it cannot be ruled out on imaging
• People who have a build-up of fluid around the lungs, abdomen, or heart that needs draining or special treatment
• People who have an infection that requires intravenous (drip) antibiotics, antiviral, or antifungal medicines
• People with active hepatitis B or C infection (certain past infections with specific blood test results may still be eligible — confirm with the trial site)
• People who have active or symptomatic brain tumours that have spread from the main cancer, or who still need steroids or seizure medicines to manage brain symptoms — those with treated and stable brain metastases may be eligible (confirm with trial site)
• People with significant eye (corneal) disease, as assessed by the treating doctor
• People who have previously been treated with a specific type of cancer drug called an ADC containing an exatecan-based topoisomerase I inhibitor
• People who still have unresolved side effects from past cancer treatment rated above a mild level — some stable, long-term mild side effects may be acceptable (confirm with trial site)
• People who have a condition affecting their digestive system that would stop them from swallowing or absorbing a tablet form of medication (such as severe nausea, bowel problems, or a significant history of bowel surgery or blockage)
• People with active or recent autoimmune or inflammatory conditions such as Crohn's disease, ulcerative colitis, lupus, rheumatoid arthritis, or a history of organ transplant requiring immune-suppressing medicines — some exceptions may apply (confirm with trial site)
• People who have tested positive for HIV, or who have active or a documented history of tuberculosis or primary immune deficiency
• People with untreated cancer that has spread to the brain or spinal cord — those with stable, treated brain metastases not requiring steroids for at least 4 weeks may not be excluded (confirm with trial site)
• People who have a second active cancer — exceptions may include certain treated skin cancers or other cancers with no sign of disease for 3 or more years (confirm with trial site)
• People who have received a live vaccine within 30 days before starting the trial or within 30 days of receiving the study treatment
• People currently taking certain medications that strongly affect how the body processes a drug called afatinib, and who cannot stop taking these at least 2 weeks before starting treatment
• People with certain heart rhythm or electrical abnormalities on an ECG, low blood pressure, known reduced heart pumping function, a history of cardiomyopathy, severe heart valve disease, stroke, or other serious heart conditions (confirm specific criteria with trial site)
• People with serious uncontrolled conditions such as uncontrolled diabetes, seizures, bleeding disorders, severe lung disease, or severe Parkinson's disease
• People who have had major surgery within 28 days before the first dose
• People with serious uncontrolled illness, uncontrolled high blood pressure, active infections, serious ongoing digestive problems, or mental health or social circumstances that would make it difficult to follow the trial requirements
• People with a history of primary immune deficiency
• Female patients who are pregnant or breastfeeding, or anyone of reproductive potential who is not willing to use effective contraception as required by the trial
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have had an organ transplant from another person
• People with significant lung conditions such as blood clots in the lungs within the past 3 months, severe asthma, severe chronic lung disease, or an autoimmune condition affecting the lungs — or people who have had a complete removal of one lung

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