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 at least 18 years old
• People who have a solid tumour cancer that has spread or cannot be surgically removed, and whose cancer has continued to grow after standard treatments or who are not eligible for standard treatments
• People whose general health and ability to carry out daily activities meets a recognised medical scoring level of 0 or 1 on the ECOG scale (meaning fully active or restricted in strenuous activity only) (confirm with trial site)
• People whose cancer has at least one area that can be measured using standard imaging criteria known as RECIST v1.1 (confirm with trial site)
• People whose bone marrow is producing enough blood cells, as shown by blood tests taken within 14 days before starting treatment (confirm with trial site)
• People whose liver is functioning well enough, as shown by blood test results within accepted ranges taken within 14 days before starting treatment (confirm with trial site)
• People whose kidneys are working well enough, based on a calculated kidney function score of at least 60 mL/min, and whose urine protein levels are below a certain threshold (confirm with trial site)
• People whose heart is pumping well enough, with the heart's left side pumping at least 50% of its capacity (confirm with trial site)
• People whose blood clotting levels are within an acceptable range (confirm with trial site)
• People who are willing and able to sign a consent form approved by an ethics committee before any study-related procedures begin
• People who agree to use highly effective contraception for at least 4 months after the final dose of the study treatment, if they are able to have children and have not had a surgical procedure to prevent pregnancy
• People whose side effects from previous cancer treatments have reduced to a mild level (Grade 1 or lower) before joining the trial

Who may not be able to join:

• People whose cancer started in the brain or spinal cord (though people with stable brain metastases — meaning cancer that has spread to the brain from elsewhere and has been stable for at least 4 weeks after treatment, without needing steroids — may still be considered)
• People who have received a blood transfusion within 14 days before starting the study treatment
• People who have serious conditions affecting the heart, lungs, kidneys, liver, or brain that the enrolling doctor believes could interfere with the study treatment
• People with a history of severe heart disease
• People whose heart's electrical activity shows a specific measurement (QTcF interval) above 470 milliseconds on a heart tracing test
• People who weigh more than 115 kg (approximately 253 lbs)
• People who are known or suspected to be pregnant or who are breastfeeding
• People whose diastolic blood pressure (the lower number in a blood pressure reading) is below 60 mmHg or above 110 mmHg
• People who have an illness that is not currently under control
• People who live in a long-term care facility or who are imprisoned
• People who have previously received any medication containing a substance called MMAE
• People who have previously received any medication that targets a protein called SORT1
• People who have taken part in another clinical trial involving a drug, medical device, or certain procedures within the 30 days before joining this study
• People who have received chemotherapy or other systemic cancer treatments within 14 days or 5 half-lives (whichever is shorter) before the first dose — or within 42 days for certain specific chemotherapy drugs (nitrosoureas or mitomycins)
• People who have had major surgery within 28 days before the first dose of the study drug
• People who have had a stroke within 6 months before the planned start of treatment
• People who currently have eye-related side effects causing noticeable symptoms
• People who have a history of a lung condition called interstitial lung disease (ILD) or pneumonitis that required steroid treatment, who currently have this condition, or where this condition cannot be ruled out based on scans done before joining the trial
• People who have nerve damage in their hands or feet (peripheral neuropathy) that is more than mildly symptomatic (above Grade 1)

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