Early 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 are willing to follow all the rules and requirements set out in the study plan
• People who are able to give their free and informed agreement to take part, after understanding what the study involves
• People who are 18 years of age or older at the time of signing the consent form
• People who are expected to live for more than 12 weeks
• People who are able to carry out normal daily activities with little or no limitation (a measure doctors use called ECOG score 0 or 1)
• People whose body weight and height fall within a specific range: a BMI between 18.0 and 35.0, weighing at least 50 kg and no more than 120 kg
• People who are in generally good health based on medical history, physical checks, vital signs, and heart tracing (ECG) at the time of screening
• People whose liver and kidney are functioning well enough, based on blood test results at screening (confirm specific values with the trial site)
• People without any other significant abnormal blood test results, as assessed by the study doctor
• Female participants who have been through menopause for at least one year, or who have had surgery that means they cannot become pregnant (such as removal of the ovaries, hysterectomy, or tubal ligation)
• Male participants who are sexually active with a female partner who could become pregnant must agree to use effective contraception and must not donate sperm until at least 3 months after receiving the study drug

For specific cancer types, people may also need to meet these criteria:

• People diagnosed with colon cancer (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People diagnosed with rectal cancer (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People diagnosed with bone or soft-tissue sarcoma (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People diagnosed with breast cancer (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People with a suspected or confirmed diagnosis of non-small cell lung cancer (any stage I–IV), based on scans or cell testing, who are receiving standard pre-surgery treatment
• People diagnosed with squamous cell cancer of the head and neck (including the mouth, throat, nose, voice box, or related areas), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People diagnosed with oesophageal or stomach cancer (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People with a suspected or confirmed diagnosis of pancreatic cancer (any stage I–IV), based on scans or cell testing, who are receiving standard pre-surgery treatment
• People diagnosed with invasive bladder cancer (any stage I–IV), confirmed by tissue examination, who are receiving standard pre-surgery treatment
• People with a suspected or confirmed diagnosis of a high-grade brain tumour called glioblastoma, based on scans or biopsy, who have a reasonable level of daily functioning (Karnofsky score of at least 70%) and are receiving standard treatment

Who may not be able to join:

• People with a mental health condition, cognitive difficulty, or behavioural issue that the study doctor believes would affect their ability to understand or follow the study requirements
• People whose veins are not suitable for the blood draws and injections needed in the study
• People who are closely related to, or directly dependent on, a member of the study team, or who are employed in the relevant departments at the study hospital or affiliated organisations
• People whose medical history or examination results suggest a condition that, in the study doctor's opinion, makes it inadvisable for them to receive the study drug, or that could affect study results
• People who have taken part in another clinical trial involving a drug or medical device within 30 days before receiving the study drug
• People who have another active cancer at the same time, or who have been treated for a second cancer within the past year, unless it is one of the cancer types included in this study — with the exception of certain skin cancers that were fully treated at least 90 days before screening
• People with significant heart problems, including a pumping function below 35%, a prolonged heart rhythm measurement on ECG, irregular heartbeat, or other notable heart abnormalities found at screening
• People with abnormal vital signs (such as blood pressure, heart rate, or temperature) that the study doctor considers a reason to exclude them from the study
• People with any other disease, abnormal test result, or physical finding that could make the study drug unsafe for them or make the study results difficult to interpret
• People who have had a major surgical procedure (unrelated to their cancer diagnosis) within four weeks before receiving the study drug
• People with a current or very recent infection (within 7 days before the study drug is given), including a fever above 38.0°C, a confirmed infection, or symptoms of infection — or who have taken antibiotic tablets or infusions within 7 days before the study drug is given
• People who have a major surgery planned during the study period that is unrelated to their tumour (emergency surgeries are an exception)
• People who have previously had a bone marrow transplant from a donor, or a transplant of a solid organ
• People with a history of severe allergic reactions, or a known allergy to any of the drugs or ingredients used in this study (mild allergies without serious symptoms may be acceptable — confirm with the trial site)
• People with any other medical condition, abnormal test result, or physical finding that the study doctor believes would make participation unsafe or interfere with study results

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