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 aged 18 to 75 years old (for Stage Ia) or aged 18 and over (for Stage Ib), of any gender
• People with a life expectancy of at least 3 months
• People diagnosed with locally advanced or spread-out HER2-positive or HER2-negative breast cancer, or certain other solid tumour cancers
• People able to provide a tumour tissue sample (either stored within the last 3 years or newly collected)
• People who have at least one measurable tumour outside the brain, as defined by standard measurement criteria (RECIST v1.1)
• People with a good general activity level (rated 0 or 1 on a standard performance scale, meaning fully active or able to carry out light work)
• People whose side effects from previous cancer treatments have mostly resolved to a mild or minimal level
• People with normal or near-normal heart pumping function (left ventricular ejection fraction of 50% or more)
• People whose blood counts and organ function meet the study's required levels, without needing a blood transfusion or growth factor support in the 14 days before starting the study drug
• People with normal blood clotting levels within the required ranges
• Women of childbearing potential who have a negative pregnancy test within 7 days before starting treatment and who are not breastfeeding; all participants (male or female) are expected to use effective barrier 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 other anti-cancer treatments within 4 weeks (or within 5 half-lives of that drug) before the first dose; or within 6 weeks for certain chemotherapy drugs (mitomycin or nitrosoureas); or certain oral chemotherapy drugs such as fluorouracil (confirm with trial site for specific timing)
• People with a history of serious heart disease
• People with certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• People with active autoimmune or inflammatory conditions
• People diagnosed with another cancer within the past 5 years before starting the trial
• People who have had unstable blood clot events requiring treatment within the 6 months before screening (clots related to intravenous infusions are excluded from this criterion — confirm with trial site)
• People with high blood pressure that remains poorly controlled despite taking two blood pressure medications (systolic above 150 mmHg or diastolic above 100 mmHg)
• People with a history of lung inflammation (interstitial lung disease) that required steroid treatment, or who currently have lung inflammation or radiation-related lung damage of a certain severity, or where such a condition is suspected
• People with poorly controlled blood sugar levels
• People with lung conditions that cause serious breathing problems
• People with brain or spinal cord tumours, or cancer that has spread to the brain and has not responded to local treatment
• People with a known allergy to the study drug (BL-M17D1) or similar types of antibody-based medicines
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who have previously received high cumulative doses of a specific type of chemotherapy called anthracyclines, beyond the amount allowed by the study protocol
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People who have had a serious active infection requiring treatment in the 4 weeks before consent, or signs of a lung infection in the 2 weeks before consent
• People with large or symptomatic fluid build-up in the body that is not well controlled
• People who have taken part in another clinical trial within 4 weeks before the first dose
• People who are pregnant or breastfeeding
• People with superior vena cava syndrome who cannot receive fluid replacement (confirm with trial site)
• People with a history of severe neurological or psychiatric illness
• People with significant unhealed wounds, ulcers, or fractures within 4 weeks before signing the consent form
• People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form
• People with a history of bowel obstruction, inflammatory bowel disease, large bowel surgery, Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea
• People who are planning to receive a live vaccine, or who have received one within 28 days before the first dose
• People whom the trial investigators consider unsuitable for other reasons

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