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
- Adults aged 18 years or older.
- People with breast cancer (during certain parts of the trial, other cancer types may also be considered — confirm with trial site).
- People who are able to provide a tumor tissue sample that tests positive for a protein called EGFR, as confirmed by the trial's central laboratory.
- People who have at least one measurable area of cancer outside the brain, as assessed using standard measurement guidelines (this requirement may not apply during certain early phases of the trial — confirm with trial site).
- People whose general physical health is rated at a good to fully active level on a standard medical scale (ECOG score of 0 or 1).
- People whose expected survival is at least 3 months.
- People whose blood, kidney, liver, and clotting functions all meet the required levels on tests done within 7 days before starting treatment.
- People who agree to use effective contraception from the time of signing the consent form until 6 months after the last dose.
- People who are willing to take part, understand what the study involves, and sign a written consent form.
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 active cancer that has spread to the brain or the lining of the brain or spinal cord (though people with previously treated and stable brain metastases may be considered).
- People who have previously been diagnosed with a type of breast cancer that is HER2-positive (this applies to certain parts of the trial — confirm with trial site).
- People who have previously been treated with a type of drug called an antibody-drug conjugate (ADC) that contains a topoisomerase I inhibitor (this applies to certain parts of the trial — confirm with trial site).
- People who have a known allergy to any ingredient in the trial drugs SYS6010 or SYH2051, or to humanised monoclonal antibody treatments.
- People who still have side effects from previous cancer treatments that have not improved to a mild level or resolved (unless the treating doctor determines there is no safety concern).
- People who have not completed the required waiting period after previous medications or treatments, as set out in the trial rules.
- People with a history of serious heart or stroke-related conditions.
- People who have a history of, or currently have, a lung condition called interstitial lung disease or non-infectious pneumonia, or whose screening scans cannot rule out these conditions.
- People with a thyroid condition that requires medication, unless the condition is fully controlled and no dose changes to that medication are needed.
- People who have had a serious infection within the 4 weeks before starting the trial drug.
- People who have previously had to stop EGFR-targeted therapy for one month or more because of skin side effects, or who currently have a skin condition that requires medication.
- People with digestive conditions or gut problems that could significantly affect how the body absorbs the trial drug (for example, ulcers, severe nausea or vomiting, diarrhoea, or problems absorbing nutrients).
- People with uncontrolled fluid build-up around the lungs or abdomen.
- People with active hepatitis B, hepatitis C, syphilis, HIV infection, or AIDS.
- People who the trial doctor considers unsuitable for any other reason.
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: 86-0311-69085587
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
Primary endpoints
Dose-limiting toxicity(DLT) occurrence and incidence; Adverse events (AE) occurrence and incidence; Objective response rate (ORR) per RECIST v1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.