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:

• Adults aged 18 or older at the time of signing the consent form
• People who have been confirmed by tissue testing to have metastatic or advanced cancer of one of the following types: urothelial, cervical, ovarian epithelial, triple-negative breast, HR+/HER2- breast, pancreatic ductal adenocarcinoma, gastric adenocarcinoma, esophageal carcinoma, non-small cell lung, or colorectal cancer
• People whose cancer has continued to grow or spread despite standard treatments, whose cancer has returned after treatment, or who have chosen not to pursue standard treatment
• People whose cancer can be measured using standard imaging criteria (confirm with trial site)
• People with a good general physical functioning level, rated 0 or 1 on a standard medical scale (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• People whose heart is pumping at 50% or greater efficiency, as shown by a heart scan
• People whose heart electrical activity test (ECG) shows no significant problems and falls within specific normal ranges for heart rhythm (confirm with trial site)
• People whose blood oxygen level is at least 90% when breathing normal room air
• People whose liver, kidneys, and other organs are functioning adequately based on blood tests at screening
• People who are willing and able to sign a written consent form
• People who are willing to follow all study requirements, including having tissue biopsies taken and attending all scheduled clinic visits
• Men who are willing to avoid donating sperm during the study and for 4 months after the last dose of the study treatment
• Men and women who could become pregnant who are willing to use a highly effective form of contraception during the study

Who may not be able to join:

• People with active cancer spread to the brain or the lining of the brain, unless the brain metastases were previously treated and have been stable on scans for at least 4 weeks, the person is clinically stable, and no steroid treatment has been needed for at least 14 days before starting the study drug
• Women who are pregnant or breastfeeding
• People who have had major surgery (such as liver or joint surgery) within the past 28 days
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant
• People with spinal cord compression that has not been fully treated with surgery and/or radiation
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that regularly requires draining
• People who have had any acute illness, including a fever above 38°C (100.4°F), within 7 days before starting the study
• People who have had an active bacterial, fungal, or viral infection within 7 days before starting the study, or who have tested positive for COVID-19 within that period
• People with an active infection with HIV, hepatitis B, or hepatitis C
• People with another current or recent cancer, with limited exceptions: adequately treated skin cancers (basal or squamous cell), certain in-situ cancers that were fully treated with no recurrence for at least 2 years, or a previous cancer that was completely removed and has been in full remission for at least 2 years
• People with a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People who previously experienced severe immune-related side effects (grade 3 or higher) such as lung, bowel, liver, or kidney inflammation from prior treatment — certain skin or hormone-related immune side effects may be acceptable if steroids are no longer needed and any hormone replacement is stable (confirm with trial site)
• People with an active autoimmune disease unrelated to their prior cancer treatment that has required systemic treatment within the past year
• People with a history of significant heart failure symptoms or serious heart rhythm problems or other major heart conditions within the past 12 months
• People who still have unresolved side effects from previous cancer treatments (above a mild level), with some exceptions for ongoing manageable side effects such as nerve tingling or certain blood test abnormalities (confirm with trial site)
• People who have received radiation therapy within 2 weeks of starting the study drug
• People who have received chemotherapy, immunotherapy (such as checkpoint inhibitors or monoclonal antibodies), or targeted cancer therapy within 28 days or 5 half-lives of the drug (whichever is shorter) before starting the study drug
• People who have received an anti-cancer vaccine within 12 weeks of starting the study drug
• People who have received a COVID-19 mRNA vaccine within 6 weeks of starting the study drug
• People who have received a live vaccine within 6 weeks of starting the study drug
• People who have received a red blood cell or platelet transfusion within 2 weeks of starting the study drug
• People with a known allergic reaction to any ingredients in the study drug
• People currently enrolled in another interventional clinical trial within 28 days or 5 half-lives of another study drug (whichever is shorter) before starting this study
• People who have any other condition that the trial doctor considers would make participation unsafe or unsuitable

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