Phase 1 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
- The person has voluntarily agreed to take part, signed a consent form, and is willing and able to follow the study procedures.
- The person is a woman aged 18 to 70 years old (age calculated on the day the consent form is signed).
- The person has been diagnosed with breast cancer that cannot be surgically removed, has spread locally, or has spread to other parts of the body (stage IIIB/C or IV), and the cancer tests negative for the HER2 protein (diagnosed according to current guidelines).
- The person has triple-negative breast cancer that has gotten worse or could not be tolerated after at least one chemotherapy treatment, OR has hormone receptor-positive breast cancer (ER and/or PgR positive) that has not responded to at least one hormone therapy or CDK4/6 inhibitor therapy.
- The person has a specific genetic marker called HLA-A*02:01, confirmed through a blood test.
- The person's tumor biopsy has tested positive for a protein called FAM53B-219aa.
- The person has not previously received any cell infusion therapy or cancer vaccine treatment.
- The person has had enough time since their last cancer treatment: no anti-blood vessel growth drugs in the past 4 weeks, no chemotherapy or targeted therapy in the past 3 weeks, no radiation therapy in the past 2 weeks, and no hormone therapy in the past 1 week. In the expansion phase of the trial, if immune checkpoint inhibitor drugs (the type used in this study) were used in earlier treatment, at least 12 months must have passed before joining.
- The person has at least one area of cancer that can be measured using standard imaging criteria (RECIST v1.1); if that area was previously treated with radiation, it must show clear signs of growth after the radiation to count as measurable.
- The person has recent tumor tissue available from their breast cancer that can be tested for cancer type and a protein called PD-L1, unless obtaining the tissue is not possible or would be unsafe (confirm with trial site).
- The person has a performance status score of 0 or 1 on a standard scale used by doctors to measure how well a person is able to carry out daily activities (ECOG scale).
- The person is expected to live for at least 12 weeks.
- The person's blood, liver, kidney, heart, and lung function all meet specific minimum levels required by the study, based on blood and other tests taken within 14 days before the procedure (without the use of blood products or growth factor medications during that time). The specific requirements are:
- Blood counts: sufficient levels of neutrophils, lymphocytes, platelets, and hemoglobin.
- Liver function: liver enzyme and bilirubin levels within accepted ranges (with slightly different limits allowed for people with confirmed liver or bone spread, or a condition called Gilbert's syndrome).
- Kidney function: creatinine levels within an acceptable range.
- Blood clotting: clotting test results within an acceptable range.
- Heart function: the heart is pumping at least 50% of its capacity on an ultrasound.
- Lung function: a breathing test shows at least 60% of normal airflow.
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.
- The person's breast cancer is progressing rapidly, as judged by the treating doctor.
- The person has active cancer spread to the brain or the lining around the brain, unless it is stable, not currently requiring medication, and not reliant on hormones — and stable treated brain spread must be confirmed with at least two brain scans taken at least 4 weeks apart (one after treatment and one during the study screening period).
- The person has compression of the spinal cord that has not been relieved by surgery and/or radiation therapy (people whose symptoms have improved for at least 1 week before the surgical sampling step may be considered).
- The person has uncontrolled fluid build-up around the lungs, heart, or abdomen (people with a drainage tube already in place may be considered).
- The person has cancer-related pain that cannot be controlled, as judged by the treating doctor; people needing pain medication must have a stable pain management plan before joining, and any lesions suitable for palliative radiation should be treated first.
- The person has been diagnosed with another cancer in the past 5 years, with exceptions for certain treated skin cancers and a specific type of non-invasive breast condition after surgery.
- The person has a significant history of heart problems, including severe heart failure, unstable chest pain, a heart attack in the past 3 months, or any irregular heart rhythm requiring treatment.
- The person has a lung condition called interstitial pneumonia, currently active significant pneumonia at the time of screening, or other respiratory conditions that seriously affect lung function.
- The person has an active infection requiring antibiotic treatment taken by mouth or through a drip (topical antibiotic use is allowed), or has an unexplained fever above 38.5°C at screening (fever caused by cancer is excluded).
- The person has had a blood clot event in the past 5 months, such as a stroke, deep vein thrombosis, or a blood clot in the lungs.
- The person is currently in another clinical trial receiving an experimental drug, or has received an experimental drug within the last 4 weeks (people in a follow-up phase only, with at least 4 weeks since the last experimental drug or device, may be considered).
- The person has a known psychiatric disorder, or a history of alcoholism or drug abuse.
- The person is pregnant or breastfeeding.
- The person has an active autoimmune disease, a history of autoimmune disease, or a condition requiring ongoing use of corticosteroid or immune-suppressing medications above a certain dose (hormone replacement therapies for specific conditions are allowed).
- The person has a congenital or acquired immune deficiency, such as a positive HIV test.
- The person has had active tuberculosis in the past year, or had tuberculosis more than a year ago but did not receive proper treatment for it.
- The person has active hepatitis B or hepatitis C; people with certain hepatitis B or C markers in their blood may be considered if virus levels are below a specific threshold and they receive antiviral treatment and regular monitoring during the trial.
- The person has active syphilis.
- The person has received a live attenuated vaccine (a type of vaccine using a weakened live virus) within 4 weeks before joining, or plans to receive one during the trial.
- The person has previously had a bone marrow or organ transplant from another person.
- The person has a known allergy to any of the study drugs or their components, including the cell vaccine, certain preservatives, proteins, or other ingredients used in the treatments.
- The person has taken part in a clinical trial using experimental immune therapies (such as certain antibodies, immune cell treatments, or cytokines) within the last 6 months.
- The person has a history of nerve damage rated at Grade 2 or above on a standard severity scale.
- The person is currently taking any medication that is not permitted to be combined with the study treatments, unless it was stopped at least 7 days before joining.
- The person has any condition, treatment, or abnormal test result that the treating doctor believes could interfere with the study results, prevent them from completing the study, or make participation not in their best interest.
- The person has any other condition that the treating doctor believes may affect their safety or ability to comply with the study.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Erwei Song, M.D.. Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phone: +86 13632394954
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
Incidence of Dose-Limiting Toxicity (DLT); Incidence of Grade≥3 Treatment-Emergent Adverse Event (TEAE)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.