Phase 1 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 metastatic or inoperable breast cancer or gastrointestinal cancer, confirmed by tissue biopsy.
• People whose cancer has continued to grow or spread after at least one standard treatment.
• People with pancreatic or esophageal cancer who have received no more than two chemotherapy regimens in the last two years; people with breast or gastrointestinal cancer who have received no more than three chemotherapy regimens in the last two years.
• People whose tumour shows certain levels of a protein called HER-2 (measured as 1+, 2+, or 3+ on a test called IHC) or over-expression of a protein called EGFR (measured by IHC or FISH tests) — if these tests have not already been done, the trial site will require them to be completed before enrolment.
• People with a history of brain metastases that have been treated, are stable for at least 3 months, and who are no longer taking steroid medications for them.
• People who are mobile and able to carry out basic daily activities (confirmed with trial site using a standard performance scale).
• People whose blood counts, liver function, and kidney function meet the specific levels required by the trial.
• People who are at least 3 weeks past their last surgery, chemotherapy, radiation, or other cancer treatment, and who have recovered from side effects of prior treatment (nerve-related side effects must be mild or minimal).
• People with hormone receptor-positive breast cancer who are on stable hormone-blocking therapy and whose tumour shows at least a low level of HER-2 (1+ or 2+ on IHC).
• People aged 18 years or older.
• Women who could become pregnant must have a negative pregnancy test before joining.
• All participants must agree to use effective contraception throughout the trial.
• People who have had a heart function scan (echocardiogram or MUGA) showing the heart is pumping at a normal level (50% or higher).
• People who are able to understand the study information and are willing to sign a consent form after being fully informed about the trial.

Who may not be able to join:

• People whose tumour tests show no HER-2 expression (scored as 0 on IHC and confirmed by FISH) and low or absent EGFR expression.
• People currently taking targeted cancer therapies such as CDK 4/6 inhibitors or mTOR inhibitors combined with hormone-blocking therapy.
• People who test positive on a skin sensitivity test for specific components of the trial vaccine (confirm with trial site).
• People who have an active infection currently requiring antibiotic treatment, or who have not been off antibiotics for at least 3 weeks.
• People with a known active infection of HIV, hepatitis A, hepatitis B, or hepatitis C.
• People with serious, uncontrolled heart or lung conditions, such as heart failure, active chest pain from heart disease, serious irregular heart rhythms, or severe breathing problems — though the treating doctor may consider exceptions for people whose condition has been stable for at least 6 months.
• People who need, or are likely to need, corticosteroids or other immune-suppressing medications for another medical condition.
• People who have had their spleen removed.
• People with active autoimmune diseases such as rheumatoid arthritis, lupus, scleroderma, or related conditions — though the treating doctor may consider exceptions for people whose condition has been stable for at least 6 months.
• People who have previously had a severe allergic (anaphylactic) reaction to any vaccine.

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