Phase 2 Oesophageal 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 aged 18 to 75 years old
• People of any gender
• People who have locally advanced or metastatic gastrointestinal cancer, such as esophageal cancer, gastric cancer, or colorectal cancer
• People whose life expectancy is at least 3 months
• People who are willing to sign a consent form and follow the study's requirements
• People who are able to provide stored or fresh tumour tissue samples from within the past 2 years
• People who have at least one tumour that can be measured using standard imaging criteria (confirm with trial site)
• People whose physical functioning is rated at a good or near-normal level (ECOG score of 0 or 1 — confirm with trial site)
• People whose side effects from previous cancer treatments have mostly recovered to a mild or resolved level
• People with healthy enough heart function, with the heart pumping at 50% or greater capacity
• People who have not needed a blood transfusion or certain blood-boosting medications in the 14 days before screening, and whose organ function meets the study's required levels
• People whose blood clotting levels fall within the study's acceptable range (confirm with trial site)
• People with a urine protein level within the study's acceptable limits
• Women of childbearing age who test negative for pregnancy within 7 days before starting treatment, and who are not breastfeeding; all participants are advised to use effective contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have received chemotherapy, biological therapy, or certain other cancer treatments within 4 to 6 weeks before the first dose (the timeframe depends on the specific treatment used)
• People who have previously been treated with a certain type of antibody-drug therapy (ADC drug using a topoisomerase I inhibitor), if they would be joining the BL-B01D1 treatment group, or who have received immune-modifying drugs within 2 weeks before the first dose
• People who have needed regular steroid medications (taken throughout the body, not just locally) within 2 weeks before the first dose
• People who previously received immunotherapy and experienced a serious immune-related side effect (grade 3 or higher), or a moderate or severe immune-related heart inflammation (grade 2 or higher)
• People with a history of serious heart disease
• People with certain heart rhythm or electrical problems, including a specific type of irregular heartbeat or heart block (confirm with trial site)
• People with active autoimmune or inflammatory conditions
• People who have been diagnosed with another cancer within the past 5 years
• People with poorly controlled diabetes, poorly controlled high blood pressure, or a history of hypertensive crisis or related brain complications
• People with significant lung disease, including a history of or current interstitial lung disease, or a diagnosis of radiation-related lung inflammation of grade 1 or higher
• People who have had an unstable blood clot requiring treatment within 6 months before screening (clots related to IV infusions may be excluded from this — confirm with trial site)
• People with uncontrolled fluid build-up around the heart, lungs, or abdomen
• People with active cancer that has spread to the brain or central nervous system
• People with a known allergy to the study drugs (BL-B01D1 or SI-B003) or similar types of antibody-based medicines
• People who have had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People with a serious active infection requiring treatment throughout the body, such as severe pneumonia or blood infection
• People who are currently participating in another clinical trial, or who have done so within 4 weeks before the first dose
• People who have received a live vaccine within 4 weeks before the first dose
• People with a history of mental illness or substance misuse that would make it difficult to follow the study's requirements
• People the trial investigator considers unsuitable for any other reason

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