Phase 1 Oesophageal 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 sign a consent form and follow the study plan.
• People of any gender are eligible.
• People aged 18 to 75 years old (for phase Ia of the study), or aged 18 and older (for phase Ib of the study).
• People with an expected survival of at least 3 months.
• People who have been diagnosed with locally advanced or metastatic triple-negative breast cancer, or another solid tumour, confirmed by laboratory testing of tissue or cells, where standard treatments have not worked, are not suitable at this stage, or where surgery is not an option.
• People who are able to provide a stored or fresh tumour tissue sample from within the past 3 years (if providing a sample is not possible, the trial site may still consider enrolment after review).
• People who have at least one measurable tumour that can be tracked during the trial, as assessed using standard imaging guidelines.
• People with a general health and activity level rated as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity).
• People whose side effects from previous cancer treatments have mostly recovered to a mild or absent level before joining (with some exceptions allowed, such as hair loss or mild nerve-related symptoms, as determined by the trial site).
• People whose blood, liver, and kidney function meet specific minimum levels before joining, as confirmed by blood tests (confirm with trial site for exact values).
• People whose blood clotting function falls within acceptable ranges, as confirmed by blood tests (confirm with trial site for exact values).
• People whose urine protein levels are within acceptable limits.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and all participants regardless of gender must use reliable contraception during treatment and for 6 months after treatment ends.

Who may not be able to join:

• People who have received chemotherapy, biological therapy, immunotherapy, major surgery, targeted therapy, or other cancer treatments within the past 4 weeks or 5 half-lives of the drug (whichever is shorter); or mitomycin and nitrosourea-based treatments within the past 6 weeks; or certain oral chemotherapy tablets or palliative radiotherapy within the past 2 weeks.
• People who have previously been treated with an antibody-drug combination (ADC) that targets a protein called TROP2, or an ADC that uses a specific type of chemotherapy agent known as a topoisomerase I inhibitor.
• People with a history of serious heart problems, such as significant heart failure, a past full-thickness heart attack, or unstable chest pain.
• People with certain abnormal heart rhythms detected on an ECG, including a prolonged QT interval (above specific thresholds for males and females), a complete left bundle branch block, or a significant type of heart conduction block (confirm with trial site for exact values).
• People with active autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring whole-body treatment — though some conditions such as well-controlled type 1 diabetes or hypothyroidism may be exceptions (confirm with trial site).
• People who have had a second, separate cancer diagnosis within the past 5 years, except for certain skin cancers or early-stage cancers that have been fully removed.
• People who have had a serious blood clot event — such as a deep vein thrombosis, arterial clot, or pulmonary embolism — requiring active treatment within the 6 months before screening (clots related to IV infusion lines are excluded from this criterion).
• People with active, symptomatic cancer that has spread to the brain or central nervous system — though people with stable brain metastases meeting specific medical criteria may be considered (confirm with trial site).
• People with a known allergy to the type of antibody used in the study drug or to any of its ingredients.
• People who have previously received an organ transplant or a bone marrow transplant from a donor.
• People who received high cumulative doses of a class of chemotherapy drugs called anthracyclines during previous treatment, above a specified threshold (confirm with trial site for exact value).
• People who test positive for HIV, have active tuberculosis, or have an active hepatitis B or hepatitis C infection at levels above specified limits.
• People with active infections that require whole-body treatment, such as severe pneumonia or blood infections.
• People who have taken part in another clinical trial within 4 weeks before the first dose of this study.
• People whom the trial investigators consider unsuitable for participation for other reasons.

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