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 (for the first stage of the trial) or aged 18 and over (for the second stage).
• People whose doctors estimate they are likely to live for at least 3 more months.
• People with breast cancer or another solid tumour that has been confirmed by laboratory testing, cannot be removed by surgery, has spread locally or to other parts of the body, and has not responded to standard treatments or for whom standard treatments are not an option.
• People who are able to provide stored tumour tissue samples (taken within the last 3 years) or a fresh tissue sample from a tumour site.
• People who have at least one measurable tumour site outside the brain, as defined by standard measurement guidelines (RECIST v1.1).
• People with a good general level of physical functioning (rated 0 or 1 on a standard scale used in cancer care, known as the ECOG scale — confirm with trial site if unsure what this means).
• People whose side effects from any previous cancer treatment have largely resolved to a mild level or better.
• People with no serious heart problems and with a heart pumping function of at least 50% (measured by a standard heart scan).
• People whose blood counts and organ function meet the required levels, without having needed a blood transfusion or growth-factor injections in the 14 days before starting the trial.
• People with normal or near-normal blood clotting results.
• People with low or acceptable levels of protein in their urine.
• Women of childbearing age who test negative for pregnancy within 7 days before starting treatment and who are not breastfeeding. All participants, regardless of gender, are required to use effective contraception throughout the treatment period and for 6 months after it ends.

Who may not be able to join:

• People who have received chemotherapy, biological therapy, or other anti-cancer treatments within 4 weeks or 5 half-lives before the first dose; or who received specific chemotherapy drugs (mitomycin or nitrosoureas) within 6 weeks before the first dose; or who are currently taking oral cancer medicines such as fluorouracil.
• People with a history of serious heart disease.
• People with certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, or third-degree heart block (confirm with trial site if unsure what these mean).
• People with active autoimmune or inflammatory conditions.
• People who currently have, or have previously had, another type of cancer.
• People who have had a blood clot event requiring treatment within the 6 months before screening (clots related to an infusion line are an exception — confirm with trial site).
• People whose high blood pressure is not well controlled even with two blood pressure medications (specifically, if the reading remains above 150/100 mmHg).
• People whose blood sugar levels are poorly controlled.
• People who have had lung inflammation related to radiation treatment, or who have a current or past history of a lung condition called interstitial lung disease (ILD), or in whom such a condition is suspected.
• People with other lung conditions that cause serious breathing difficulties.
• People with tumours that started in the brain or nervous system, or with cancer that has spread to the brain and has not responded to local treatment.
• People with a known allergy to certain types of laboratory-made antibodies, or to any ingredient in the study drug (BL-B16D1).
• People who have previously received an organ transplant or a bone marrow/stem cell transplant from a donor.
• People who have previously received high cumulative doses of certain chemotherapy drugs called anthracyclines, above specified limits (confirm exact limits with trial site).
• People who are HIV positive, or who have active tuberculosis, active hepatitis B, or active hepatitis C.
• People who had a serious infection within 4 weeks before the first dose, or signs of a lung infection or active lung inflammation within 2 weeks before the first dose.
• People with large or symptomatic fluid build-up in body cavities that is not well controlled.
• People who have taken part in another clinical trial within 4 weeks before the first dose.
• People with certain eye conditions, including: an active eye infection or corneal ulcer; vision in only one eye; a history of corneal transplant; dependence on contact lenses; uncontrolled glaucoma; or uncontrolled or worsening retina problems or wet macular degeneration.
• People whom the trial investigators consider unsuitable for any other reason.

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