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 one of these specific cancer types (confirmed by a laboratory test on tumour tissue): triple-negative breast cancer, HR+/HER2- or HER2+ breast cancer, non-small cell lung cancer, cervical cancer, castration-resistant prostate cancer, pancreatic cancer, head and neck cancer, endometrial cancer, ovarian cancer, stomach or gastroesophageal junction cancer, or bladder/urinary tract cancer — where the cancer cannot be surgically removed, has spread locally, or has spread to other parts of the body
• People whose cancer has come back or stopped responding to treatment, who have already tried at least 2 previous treatments, and for whom no standard treatment options remain
• People whose cancer can be measured on a scan
• People who are relatively well and able to carry out daily activities, as measured by a standard scale called ECOG performance status 0–1 (confirm with trial site)
• People whose life expectancy is at least 3 months, in the treating doctor's opinion
• People whose bone marrow, kidneys, and liver are functioning at an adequate level (confirm with trial site for specific values)
• People who have been off high-dose steroid medications for at least 2 weeks (low-dose steroids of 25 mg prednisone or less per day may be allowed — confirm with trial site)
• People who are willing to provide stored tumour tissue samples, or agree to a new biopsy if stored samples are not available
• People who are willing to have a biopsy taken during the trial, if it is safe and practical to do so

Who may not be able to join:

• People who have had major surgery within 28 days before the trial starts
• People who have not waited long enough after finishing previous cancer treatments before starting the trial (specific waiting periods apply depending on the type of treatment — confirm with trial site)
• People who have had radiation therapy within 21 days before the trial starts (limited palliative radiation may be considered — confirm with trial site)
• People who have brain metastases (cancer that has spread to the brain) that are untreated and causing symptoms, or that require steroids or anti-seizure medications to manage symptoms — treated brain metastases that are no longer causing symptoms may be allowed if high-dose steroids were stopped at least 12 weeks before the trial starts
• People who have moderate or severe loss of appetite, nausea, vomiting, or signs of a bowel blockage
• People who have or have had another cancer, unless it was a successfully treated skin cancer, an in-place cancer that was fully treated, or another solid cancer with no signs of disease for at least 1 year
• People with serious, uncontrolled other illnesses that could affect their ability to follow the study requirements
• People with a current or past history of brain or nervous system conditions such as stroke, epilepsy, inflamed blood vessels in the brain, or a degenerative neurological disease (people who had a stroke more than 6 months ago with no lasting neurological effects may be eligible — confirm with trial site)
• People with a specific heart rhythm measurement (QTcF) above 480 milliseconds, or a history of certain heart rhythm risk factors (confirm with trial site)
• People with serious, uncontrolled heart or cardiovascular disease
• People who have had a heart attack within the past 6 months, or who have an abnormal heart tracing (ECG) that the doctor considers clinically significant
• People who have previously had a solid organ transplant
• People with a known HIV, hepatitis B, or hepatitis C infection — though some people with these infections who meet specific conditions (such as undetectable virus levels and being on treatment) may still be considered for enrolment (confirm with trial site)
• People who have had an active infection requiring intravenous antibiotics, antifungals, or antivirals within the past 2 weeks
• People who have active interstitial lung disease (lung inflammation causing symptoms such as breathlessness, need for extra oxygen, or dry cough), or whose scans showed this condition within the past 6 months
• People with other medical or mental health conditions that, in the doctor's opinion, could interfere with the study or prevent them from completing it

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