Phase 2 Breast Cancer Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged 18 to 75 years old (both ages included), of any sex.
- People with breast cancer that cannot be surgically removed, has come back, or has spread to other parts of the body.
- People who have previously received no more than two rounds of chemotherapy (not counting hormone therapy) for breast cancer that has returned or spread.
- People whose tumour tissue has tested positive for HER2 (by a specific lab test result of IHC3+ or FISH+).
- People who have at least one tumour that can be measured using standard imaging guidelines (called RECIST 1.1).
- People who have recovered from side effects of previous surgery or cancer treatment, with any remaining effects being mild (Grade 1 or lower).
- People with adequate bone marrow, liver, kidney, and blood-clotting function, based on lab tests.
- People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning fully active or restricted only in physically strenuous activity).
- People who are willing to sign a consent form, follow the trial requirements, and attend follow-up visits.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with a known allergy to any ingredient in the trial drug ARX788.
- People with cancer that has spread to the lining of the brain, spread widely throughout the brain, or has active brain tumours that currently need radiation, surgery, or medication.
- People who have fluid build-up around the heart, in the lungs, or in the abdomen that is causing symptoms or needs treatment.
- People who have lung disease affecting the tiny air sacs (interstitial lung disease) that requires steroid treatment, or who have a history of lung damage from drugs or radiation, or any signs of currently active interstitial lung disease.
- People who have an eye condition — such as inflammation of the cornea, other corneal diseases, or an active eye infection — that requires medical treatment.
- People with heart failure or significant heart weakness.
- People with high blood pressure that is not well controlled.
- People with severe or uncontrolled illness affecting the body as a whole.
- People who have received a live vaccine within 4 weeks before starting the trial, or who plan to receive one during the trial.
- People who are breastfeeding, who have a positive pregnancy test at the start of the trial, or who are unwilling to use effective contraception during the trial (applies to people who could become pregnant).
- People who are unwilling or unable to stop wearing contact lenses for the duration of the trial.
- People who have received any systemic cancer treatment (other than hormone therapy, which requires a gap of at least 7 days) within 28 days — or within at least 5 half-lives of that treatment — before starting the trial.
- People who have a mental health condition or cognitive difficulty that may affect their ability to understand or follow the consent process.
- People whom the trial investigator considers unsuitable for any other reason, such as concerns about ability to follow the trial requirements.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +86 15713857388
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Objective remission rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.