Phase 1 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:

• Adults aged 18 or older who have voluntarily agreed to take part and follow the study requirements
• People of any sex
• People with a life expectancy of at least 3 months
• People with advanced or metastatic cancer that cannot be cured, originating from epithelial tissue — the trial gives priority to certain cancer types including non-small cell lung cancer (NSCLC), HER2-negative breast cancer, esophageal cancer, small cell lung cancer (SCLC), nasopharyngeal cancer, and head and neck cancers
• People with advanced breast cancer of specific subtypes (HER2-negative with positive or negative hormone receptors), whose disease has progressed after prior treatments, and who have received at least one prior chemotherapy and, where applicable, an immunotherapy drug (confirm with trial site for your specific subtype)
• People with triple-negative breast cancer (TNBC) who have received specific prior treatments including PARP inhibitors (if a BRCA mutation is present) and sacituzumab govitecan (confirm with trial site)
• People who are willing to provide stored tumour tissue samples from within the past two years (a new biopsy is strongly encouraged but not required if no stored tissue is available)
• People who have at least one tumour that can be measured on a scan (with an exception for prostate cancer patients with bone spread)
• People whose general physical functioning is rated at a good to moderate level (ECOG performance status 0 or 1)
• People whose side effects from previous cancer treatments have mostly resolved to mild or no symptoms
• People with healthy heart function, with the heart's pumping ability at 50% or above
• People with adequate bone marrow, liver, and kidney function meeting specific blood test thresholds (confirm with trial site)
• People with normal blood clotting test results within defined ranges
• People with low or no protein detected in their urine
• People who agree to use highly effective contraception during the study and for 7 months after the last dose (for women) or 4 months (for men), plus an additional barrier method such as a condom
• Women who could become pregnant must have a negative pregnancy blood test at the start of the study and must not be breastfeeding
• People with NSCLC who have specific documented gene mutations in the EGFR gene (certain mutations in Exons 18, 19, 20, or 21) confirmed before starting treatment
• People with triple-negative breast cancer (TNBC) that is locally advanced, cannot be operated on, or has spread to other parts of the body, confirmed by laboratory testing
• People with advanced esophageal or esophagogastric junction cancer that has progressed after one prior chemotherapy regimen using specific drug types (fluoropyrimidine and/or platinum-based)
• People with prostate cancer that has spread and is no longer responding to hormone-lowering treatments, and who have progressed after specific hormone-blocking drugs (such as abiraterone or enzalutamide), but have not received prior chemotherapy (prior lutetium-177 treatment is allowed)
• People with NSCLC without certain gene mutations (EGFR wild-type), with squamous cell or adenocarcinoma type, whose cancer has progressed after one prior platinum-based chemotherapy combined with an immunotherapy drug
• People with ovarian, primary peritoneal, or fallopian tube cancer that has progressed or come back after platinum-based chemotherapy (with or without a PARP inhibitor)
• People with advanced or metastatic endometrial cancer that has progressed after platinum-based chemotherapy (with or without immunotherapy)
• People with advanced or metastatic cervical cancer that has progressed after platinum-based chemotherapy (with or without immunotherapy)

Who may not be able to join:

• People who have had chemotherapy, immunotherapy, targeted therapy, or radiation within 2 weeks (or 5 half-lives, whichever is shorter) before starting the trial, major surgery within 4 weeks, or certain specific chemotherapy drugs (mitomycin or nitrosoureas) within 6 weeks
• People with a history of serious heart conditions, such as significant heart failure, a past major heart attack, or unstable chest pain
• People with a prolonged heart electrical interval (QTc greater than 470 milliseconds) or certain heart conduction problems
• People with active autoimmune or inflammatory diseases (such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring whole-body treatment), with some exceptions such as well-controlled thyroid conditions or Type 1 diabetes
• People who have been diagnosed with another cancer within the past 5 years, except for certain types of skin cancer or carcinoma in situ that have been fully removed
• People with high blood pressure that remains poorly controlled despite taking two blood pressure medications
• People with severe lung disease or a history of a specific type of lung inflammation called interstitial lung disease or pneumonitis
• People who have had a serious blood clot (such as a deep vein clot, arterial clot, or lung clot) requiring treatment within the past 6 months
• People with brain tumours that started in the brain, or with brain metastases that are active or have not been treated — people with previously treated, stable brain metastases may be considered if certain conditions are met (confirm with trial site)
• People with a known allergy to the type of antibody used in the study drug (BL-B01D1) or any of its ingredients
• People who have had a stem cell transplant (their own or from a donor)
• People who have previously received high cumulative doses of a type of chemotherapy called anthracyclines (above 360 mg/m²)
• People with a significantly low potassium level in the blood (Grade 2 or above)
• People with active HIV, active tuberculosis, active hepatitis B, or active hepatitis C infection
• People with serious active infections currently requiring treatment, such as severe pneumonia or blood infection
• People who have received another experimental drug within 4 weeks (or two half-lives, whichever is longer) before starting this trial
• People who are pregnant or breastfeeding
• People with NSCLC and certain EGFR mutations who have received more than two prior chemotherapy regimens
• People with NSCLC and a specific type of EGFR mutation called an Exon 20 insertion mutation
• People with triple-negative breast cancer who have received more than two prior chemotherapy regimens
• People with esophageal cancer who have received more than one prior chemotherapy regimen for advanced disease
• People with prostate cancer who have received any prior chemotherapy
• People with NSCLC (EGFR wild-type) who have received more than one prior chemotherapy regimen for advanced disease
• People with ovarian, endometrial, or cervical cancer who have received more than one prior chemotherapy regimen
• People who have previously been treated with certain antibody-drug therapies (ADCs) that target EGFR or HER3, or that contain a topoisomerase 1 inhibitor, with a specific exception that may apply to some TNBC patients (confirm with trial site)
• People whose overall health status or other conditions the treating doctor considers unsuitable for trial participation

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