Phase 1 Breast 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 are willing to sign a consent form and follow the study requirements
• People of any gender aged 18 to 75 years
• People with an expected survival time of at least 3 months
• People with a confirmed diagnosis of unresectable locally advanced or metastatic breast cancer or other solid tumors, where standard treatments have failed, were not tolerated, are unavailable, or cannot be accessed
• People with triple-negative breast cancer who have not previously received systemic treatment for unresectable locally advanced or recurrent/metastatic disease
• People who are able to provide stored or fresh tumor tissue samples from the past 3 years
• People who have at least one measurable tumor lesion as assessed by standard imaging criteria (RECIST v1.1)
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale used by doctors (ECOG scale)
• People whose side effects from previous cancer treatments have largely resolved to a mild level or better
• People with adequate heart function, with the heart pumping at least 50% of its capacity
• People whose blood test results show adequate organ function, without having needed blood transfusions or certain growth-stimulating medications in the 14 days before starting the study
• People with normal blood clotting levels within specified ranges (confirm with trial site)
• People with low or no protein detected in urine
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; 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 certain cancer treatments (such as biological therapy, immunotherapy, or other anti-tumour treatments) within 4 weeks or 5 half-lives before starting the study (different timeframes apply to some specific treatments — confirm with trial site)
• People with a history of serious heart disease
• People with certain heart rhythm or electrical conduction problems, such as a prolonged QT interval, complete left bundle branch block, third-degree heart block, or severe irregular heartbeat
• People with active autoimmune or inflammatory diseases
• People diagnosed with another cancer within the past 2 years
• People with high blood pressure that remains poorly controlled (above 150/100 mmHg) despite taking two blood pressure medications
• People with poorly controlled blood sugar levels or diabetic gangrene
• People with a history of, current, or suspected interstitial lung disease (a type of lung scarring or inflammation)
• People with another lung condition causing significant breathing problems
• People who have had an unstable blood clot in a vein or artery, or a pulmonary embolism, within the past 6 months that required treatment (excluding clots related to a catheter)
• People with cancer that has spread to the brain or the membranes surrounding the brain or spinal cord
• People with significant fluid build-up in body cavities (such as around the lungs or abdomen) that is causing symptoms or is difficult to control
• People with a known allergy or sensitivity to certain types of antibody-based medicines or any ingredients in the study drug (BL-B01D1)
• People whose imaging shows the tumour is growing into or wrapping around major blood vessels in the chest, neck, or throat (unless the study doctor determines this does not affect eligibility)
• People who have had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who have received a high cumulative dose of a specific class of chemotherapy called anthracyclines (above 360 mg/m²) in previous treatment
• People who test positive for HIV, or have active tuberculosis, active hepatitis B, or active hepatitis C
• People who have had a serious infection within 4 weeks before starting the study, or signs of an active lung infection within 2 weeks before starting
• People who have taken part in another clinical trial within 4 weeks before starting this study
• People whom the study doctor considers unsuitable for any other reason

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