Phase 2 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:

• Adults aged 18 or older who are able to give written consent to take part in the study.
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2).
• People whose life expectancy is estimated by their doctor to be at least 6 months.
• People who have been diagnosed with a specific type of breast cancer called HER2-low, where the cancer has either spread to other parts of the body or cannot be surgically removed, confirmed through laboratory testing of tumour tissue.
• People whose breast cancer is hormone receptor positive (HR+), meaning the cancer cells respond to oestrogen or progesterone hormones, and also classified as HER2-low (Cohort 1).
• People whose breast cancer is hormone receptor negative (HR-), meaning the cancer cells do not respond to oestrogen or progesterone hormones, and also classified as HER2-low (Cohort 2).
• People who have at least one area of cancer that can be measured on a scan, including certain bone lesions.
• People who can provide a tumour tissue sample — either stored from a previous biopsy or from a new biopsy — for testing. Those without available tissue may still be considered after discussion with the trial's lead doctor (confirm with trial site).
• People who have brain metastases (cancer that has spread to the brain) that have already been treated and are stable, provided certain timing and medication conditions are met (confirm with trial site for specifics).
• People who have already received at least one round of chemotherapy or a type of targeted drug called an antibody-drug conjugate (ADC) for their advanced or metastatic breast cancer.
• People whose blood test results meet minimum levels for red blood cells, white blood cells, and platelets.
• People whose liver function test results fall within acceptable ranges for this trial.
• People whose kidney function meets the minimum level required.
• People whose heart function, as measured by how well the heart pumps blood, is at or above the minimum level required.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have an undetectable viral load while on suppressive treatment.
• People with a history of hepatitis C who have completed treatment with no detectable virus remaining.
• People who have recovered from side effects of previous cancer treatments to an acceptable level (with the exception of hair loss and nerve-related symptoms).
• People of reproductive age who agree to use highly effective contraception, or to abstain completely from sex, during the trial and for a set period after the last dose of the study drug (at least 3 months for women and at least 5 months for men whose partners could become pregnant).
• Men who agree not to freeze or donate sperm from the time of screening until at least 5 months after the last dose of the study drug.
• Women who agree not to donate or retrieve their eggs for personal use from the time of screening until at least 3 months after the last dose of the study drug.

Who may not be able to join:

• People who have previously been treated with the study drug ARX-788 or similar drugs called auristatin analogues.
• People who have had an allergic reaction to any ingredient in ARX-788.
• People who have received another experimental or cancer-treating drug within 14 days before the first dose of the study drug (hormone therapies may be allowed up to 7 days before, confirm with trial site).
• People who have had radiation therapy to any part of the body outside the brain within 7 days before the first dose of the study drug.
• People with a current or past history of serious lung conditions such as inflamed or scarred lung tissue (interstitial lung disease or pneumonitis), unless the lung problem is directly caused by cancer that has spread to the lungs.
• People with significant lung problems, including a history of drug-related lung inflammation, past chest radiation above a certain dose with lasting effects, significant radiation-related lung scarring shown on scans, or a need for supplemental oxygen.
• People with certain serious eye conditions, including a history of cornea inflammation or active eye disease (excluding glaucoma).
• People with a history of serious heart problems such as heart failure, unstable chest pain, irregular heartbeat, or a heart attack within the past 6 months, or whose heart electrical activity reading (ECG) shows an abnormally prolonged interval.
• People who have cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis).
• People with an active physical illness or mental health condition that would make it difficult to safely receive the study treatment.
• People with an uncontrolled illness, active infection (including active COVID-19 with symptoms), or other conditions that could interfere with participation in the trial.
• People who have had another type of cancer that is still being treated or has required active treatment within the past 3 years. Some exceptions apply, such as certain skin cancers or thyroid cancer treated with curative intent (confirm with trial site for details).
• People who are currently pregnant or breastfeeding.
• People with active, uncontrolled hepatitis B, hepatitis C, or HIV infection. Those with adequately managed versions of these conditions may still be considered.

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