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 fully informed about the study and are willing and able to sign a consent form
• Adults aged 18 or older
• People who have one of the following cancer types that has been confirmed by lab testing, is locally advanced (cannot be surgically removed) and/or has spread to other parts of the body, and has continued to progress — and who have already tried all standard treatments approved for their condition, are not eligible for those treatments, or have chosen not to pursue them: cervical or vulvar cancer, small cell lung cancer (SCLC), stomach or gastroesophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), or hormone receptor-positive (HR+) breast cancer
• People whose doctor estimates they have a life expectancy of at least 3 months
• People who are generally well enough to carry out light activity and care for themselves (this is measured using a standard medical scale — confirm the specific level with the trial site)
• People who have recovered from the side effects of any previous radiation therapy, chemotherapy, or surgery to an acceptable level (with some exceptions for hair loss and mild nerve-related symptoms)
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial (the trial site will check these through blood tests)
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the trial
• Women who could become pregnant must agree to use highly effective contraception during treatment and for at least 6 months after the last dose of the study drug
• Male participants with female partners who could become pregnant must agree to use two acceptable methods of contraception, including a barrier method, during treatment and for at least 6 months after the last dose of the study drug
• Male participants must agree not to donate sperm during treatment and for at least 6 months after the last dose of the study drug
• People who are willing and able to follow all study procedures, including blood sample collection, tumor biopsies, and return visits to the clinic

Who may not be able to join:

• People who have active or suspected cancer spread to the brain or central nervous system, unless it has been fully treated with radiation therapy, the person has no symptoms, is not requiring corticosteroids above a certain dose, and repeat scans taken at least 4 weeks after completing radiotherapy show the condition is stable
• People who have had another active cancer (other than certain early-stage or skin cancers) within the past 2 years
• People with a serious uncontrolled medical condition that could interfere with taking part in the trial
• People with any other unstable or uncontrolled medical, heart, lung, kidney, metabolic, blood, or mental health condition that the study doctor believes could put them at risk or affect the trial results
• People with certain infection histories, including: an AIDS-defining illness within the past 12 months, or HIV where anti-retroviral treatment has not been established for at least 4 weeks and where the viral load is above a certain level; active hepatitis B infection (as shown by a positive surface antigen test); untreated or incompletely treated hepatitis C infection, or hepatitis C where the virus is still detectable after treatment; or a severe infection requiring intravenous (IV) antibiotics within 21 days before starting the trial
• People with any other serious active condition that the study doctor believes would make it unsafe to use an investigational drug
• People who have had major surgery within 21 days before starting the trial, or who expect to need major surgery during the study
• Women who are pregnant or breastfeeding
• People who have a known allergy to any ingredient in the study drug AVA6103, or to a similar type of drug called a topoisomerase 1 (TOP1) inhibitor
• People who have received another investigational (not yet approved) treatment within 28 days or 5 half-lives of the drug (whichever is shorter) before starting the trial
• People who have received approved cancer treatments such as chemotherapy or hormonal therapy within 14 days (or 5 half-lives, whichever is shorter) before starting the trial, with some exceptions (confirm details with the trial site)
• People who are currently taking St John's Wort, or certain other medications that strongly affect how the body processes drugs — including some antifungals, antibiotics, and pain medications (confirm the full list with the trial site)
• People taking certain other medications that interfere with specific drug-processing proteins in the body (confirm the specific medications with the trial site)
• People who are planned to be on certain other medications during the study that interact with the study drug's processing in the body (confirm with the trial site)
• People who have received a white blood cell booster injection (G-CSF) or a red blood cell or platelet transfusion within 14 days before starting the trial
• People who have received radiation therapy within 28 days before starting the trial (limited palliative radiation may be allowed with at least a 7-day gap — confirm with trial site)
• People who have received a live vaccine within 30 days before starting the trial (COVID-19 vaccines must be given more than 96 hours before the study drug)
• People whose heart's electrical activity (measured by an ECG) shows a prolonged QT interval above a certain threshold on at least two separate readings

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