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:

• You are 18 years of age or older, able to understand the study information, and can give written consent to participate
• You have been diagnosed with a type of cancer called metastatic adenocarcinoma that started in the digestive system (such as the stomach/esophagus junction, colon, rectum, pancreas, or bile ducts), confirmed by a tissue or cell sample, and previous standard treatments have not worked
• Your blood counts are at acceptable levels without needing recent blood transfusions or growth factor injections (confirm with trial site for specific numbers)
• Your liver is functioning well enough, based on blood test results being within acceptable ranges (confirm with trial site for specific numbers)
• Your kidneys are functioning well enough, based on a calculation of how well they filter your blood (confirm with trial site for specific numbers)
• If you are able to have children and are sexually active with a partner of the opposite sex, you must agree to use specific, highly effective birth control methods during the study and for a set period after finishing the study treatment
• If you are a man whose partner could become pregnant, you must agree to use a condom and spermicide throughout the study and for 3 months after your last dose, unless other conditions apply (confirm with trial site for details)
• You are willing and able to follow all the rules and requirements set out in the study plan

Who may not be able to join:

• You have a positive pregnancy test or are currently breastfeeding
• You have a known allergy or sensitivity to the study drug or any of its ingredients
• You are currently taking, or have previously taken, certain medications that are not allowed in this study (confirm with trial site for the specific list)
• You have received certain cancer treatments — such as biological therapies within the last 4 weeks, or chemotherapy, targeted therapy, or radiation within the last 2 weeks — and have not fully recovered from their side effects (some exceptions may apply, confirm with trial site)
• You have previously been treated with a specific class of cancer drugs called topoisomerase 1 inhibitors
• You currently have another active cancer (exceptions may apply if a previous cancer has been fully treated with no signs of return for at least 3 years, or was a low-risk type that was surgically removed)
• You have brain tumours that are currently unstable or worsening (those with stable, treated brain tumours may still be eligible — confirm with trial site)
• You have had a heart attack or unstable chest pain within the last 6 months, have a history of serious heart rhythm problems, significant heart failure, or a history of a prolonged QT interval (a specific heart electrical reading)
• You have active inflammatory bowel disease (such as ulcerative colitis or Crohn's disease) or have had a hole or tear in your digestive tract within the last 6 months
• You currently have a serious infection that requires antibiotic treatment
• You have HIV with a detectable level of virus in your blood, or are taking medications that may interfere with how the study drug is processed in your body
• You have active hepatitis B or hepatitis C, confirmed by blood tests showing the virus is present in your body
• You have other ongoing medical or mental health conditions that, in the doctor's opinion, could affect your safety or the accuracy of the study results
• You have taken another experimental drug (one not approved for any use) within the past 28 days or within 5 half-lives of that drug, whichever is longer

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