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 have a solid tumour (dose escalation phase) or stomach/gastroesophageal junction cancer (dose expansion phase) that is advanced, cannot be surgically removed, or has spread, and has continued to grow after at least one previous treatment.
• People whose tumour tests positive for a protein called HER2 (at any level: 1+, 2+, or 3+) or shows HER2 gene amplification on a tissue test.
• People who have never previously been treated with the drug T-DXd (also called DS-8201a).
• People in the dose expansion phase who previously received a trastuzumab-based treatment, if that treatment was considered appropriate for their situation.
• People aged 18 or older.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG performance status of 0 or 1).
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the ranges required by the trial (confirmed by blood tests taken within 7 days before starting treatment, without recent blood transfusions or certain blood-boosting injections).
• People whose heart pumping function is at least 50%, confirmed by a heart scan within 28 days before joining.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have an undetectable viral load while on appropriate suppressive treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
• People who have had brain metastases that were previously treated, with no sign of growth on follow-up brain imaging.
• People with new or worsening brain metastases or spread to the lining of the brain, if the treating doctor determines that immediate brain-specific treatment is not needed during the first cycle of the study.
• People with a previous or current second cancer, as long as that cancer or its treatment is unlikely to interfere with the study's assessments (confirm with trial site).
• People with a life expectancy of at least 3 months.
• Women who could become pregnant must have a negative blood pregnancy test within 3 days of starting treatment, and must agree to use highly effective contraception from screening until at least 7 months after the final dose; they must also not donate or collect eggs during this period.
• Women who cannot become pregnant due to surgical sterilisation or confirmed menopause are eligible; women on hormone replacement therapy whose menopausal status is uncertain may need to use contraception or pause hormone therapy (confirm with trial site).
• Male participants who could father a child must agree to use highly effective contraception from screening until at least 4 months after the last dose, and must not donate or freeze sperm during this period.
• People who are able to understand the study and are willing to sign a consent form (a legal representative may sign on behalf of a participant if needed).
• People in the dose expansion phase must be willing to have a tumour biopsy as required by the study.
• People who have had enough time since their last treatment before starting the study (waiting periods range from 2 weeks to 6 weeks depending on the type of prior treatment).

Who may not be able to join:

• People currently taking prescription or over-the-counter medicines known to significantly affect a liver enzyme called CYP3A4 (including chloroquine or hydroxychloroquine), unless these are part of an approved anti-nausea regimen used in the trial.
• People currently taking part in another clinical trial involving an experimental treatment.
• People with a history of serious allergic reactions to drugs chemically similar to the study drugs, or to other antibody-based medicines.
• People with serious lung problems, including recent blood clots in the lungs (within 3 months), severe asthma, severe chronic obstructive lung disease, restricted lung function, significant fluid around the lungs, certain autoimmune or inflammatory conditions that affect the lungs, or people who have had a lung surgically removed.
• People who need supplemental oxygen for everyday activities.
• Women who are pregnant or breastfeeding.
• People with a history of non-infectious lung inflammation (pneumonitis) or interstitial lung disease, or where this condition cannot be ruled out by imaging at the time of screening.
• People with an active infection requiring antibiotic, antifungal, or antiviral treatment at the time of starting the study (people who have fully recovered for at least 7 days before starting may be eligible).
• People with conditions that prevent normal absorption of food or medication through the gut, or who are unable or unwilling to swallow tablets or capsules.
• People currently experiencing signs or symptoms of a bowel blockage.
• People who have had a heart attack within the past 6 months, have moderate-to-severe heart failure, or have had blood test results indicating recent heart muscle injury within 28 days before joining.
• People with significant disease affecting the corneas of the eyes.
• People with fluid around the lungs, abdomen, or heart that requires drainage or a special procedure to manage.
• People with a history of a serious heart rhythm problem called Torsades de Pointes, unless all contributing risk factors have been fully corrected.
• People whose heart rhythm tests (ECG) show a prolonged electrical interval (QTc greater than 470 milliseconds), or who have a hereditary condition causing long QT syndrome.
• People who have previously been treated with a type of drug called a WEE1 inhibitor.
• People who have previously been treated with T-DXd (DS-8201a) or other drugs in the topoisomerase inhibitor class.
• People with other serious uncontrolled illnesses.
• People who have previously received an organ transplant or bone marrow transplant from another person.
• People with a significant ongoing digestive condition where diarrhoea is a major symptom, or who have moderate or severe diarrhoea at the time of screening (confirm with trial site if uncertain).
• People with compression of the spinal cord.

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