Phase 1 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 have been diagnosed with an advanced solid tumour cancer (such as head and neck, salivary gland, lung, breast, bladder, stomach, oesophageal, colorectal, or pancreatic cancer) that has been confirmed by laboratory testing and shows a specific protein called HER2 at a certain level on tumour tissue testing
• People whose cancer has been assessed by their oncologist as no longer suitable for curative treatments such as surgery, radiation, or other systemic therapies
• People whose cancer has continued to grow or spread after at least one standard treatment, or where no effective standard treatment options are available
• People who have at least one tumour that can be directly injected as part of the trial
• People whose cancer can be measured on scans using standard criteria (called RECIST 1.1)
• People whose blood counts, liver function, and kidney function fall within acceptable ranges as measured within 7 days before treatment
• People who are 18 years of age or older and are able to understand and agree to the study procedures
• People with a life expectancy of more than 12 weeks (for the initial tissue collection stage)
• People who have previously received HER2-targeted therapy, provided it was completed at least 4 weeks before joining the treatment phase
• People who are reasonably well and able to carry out some daily activities, as assessed by a standard medical scale (ECOG score of 2 or less)
• Women of childbearing potential who have a negative pregnancy test and agree to use contraception during the trial, or who are confirmed unable to become pregnant
• Male participants whose partner could become pregnant who agree to use barrier contraception during the trial

Who may not be able to join:

• People with an active autoimmune disease that requires ongoing treatment with corticosteroids above a certain dose, immune-suppressing medications, or other disease-modifying drugs
• People who have had an organ transplant, or who have been diagnosed with HIV or another condition that significantly weakens the immune system
• People who have been diagnosed with another cancer within the past 5 years, with the exception of certain skin cancers (basal cell or squamous cell), well-differentiated thyroid cancer, or localised prostate or cervical cancer
• People with a known active hepatitis B or C infection
• People who have had a heart attack within the 6 months before joining the trial
• People whose tumour is located in a position where injection would carry a significant risk of serious bleeding, such as in or near the brain or critical blood vessels
• People with uncontrolled ongoing illness, including mental health conditions or personal circumstances that the investigating doctor believes would make safe participation in the trial difficult
• People currently receiving certain other treatments that could interfere with the trial, including high-dose corticosteroids, immune-suppressing therapies, or other active cancer treatments (some exceptions may apply at certain dose levels — confirm with trial site)
• People where tumour swelling after injection could pose a serious risk of blocking the airway or other critical structures such as the bowel or ureter
• People with abnormal heart function, specifically a heart pumping capacity (LVEF) below 55%
• Women who are pregnant or breastfeeding

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