Printed from Voxsanity (voxsanity.com.au) — NCT07153965 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07153965
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 or older at the time of signing the consent form.
- People who have been confirmed through a tissue or cell sample to have triple-negative breast cancer (a type of breast cancer that does not respond to certain hormone-based treatments), based on their most recent biopsy or pathology results.
- People whose cancer is at an advanced stage that cannot be surgically removed, has come back, or has spread to other parts of the body — and where a doctor has confirmed surgery to cure it is not suitable.
- People whose cancer has progressed after receiving chemotherapy combined with a type of immunotherapy drug (called a PD-(L)1 inhibitor), under one of the following circumstances (confirm with trial site):
- The drug combination was used as a first treatment for advanced or spread disease, and the cancer progressed 3 or more months after starting it.
- The drug combination was used before or after surgery, and the cancer came back or spread within 12 months but at least 3 months after finishing it.
- The drug combination was used before or after surgery, the cancer came back 12 or more months later, and has since progressed after a further first-line treatment for advanced disease.
- People with newly diagnosed cancer that has spread to the brain, where that spread has been stable for at least 4 weeks after local treatment (such as radiotherapy), confirmed by imaging.
- People whose most recent tumour sample shows a PD-L1 combined positive score (a measure of a protein on cancer cells) of 1 or higher.
- People who have at least one area of cancer that can be measured on scans, according to standard criteria — skin-only or bone-only lesions do not meet this requirement.
- People with a performance status score of 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations in physical activity.
- People whose organs and bone marrow are functioning adequately, and who have not received certain blood-supporting treatments in the 2 weeks before starting the trial.
- People of childbearing potential (male or female) who are willing to use effective medical contraception from the time of consent until 6 months after the last dose.
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 who have previously received any treatment that specifically targets a protein called TROP2, or any drug — including certain antibody-based treatments — that targets an enzyme called topoisomerase I.
- People who have cancer that has spread to the membranes around the brain, the brainstem, or the spinal cord, or who have active cancer spread in the brain. People with previously treated brain metastases may be considered if they have been clinically stable for at least 4 weeks before starting the trial and have not needed steroids or anti-seizure medication for at least 14 days. People with untreated brain metastases that are not causing symptoms would require investigator approval (confirm with trial site).
- People with a history of serious dry eye disease, severe eyelid gland disease, or corneal conditions that prevent or slow corneal healing.
- People who have had another type of cancer within the past 3 years, unless it was a type treated locally and considered cured (such as certain skin cancers or early-stage cervical changes).
- People with uncontrolled or significant heart or blood vessel disease, or other serious uncontrolled conditions affecting the whole body.
- People who currently have, or are suspected of having, lung inflammation (interstitial lung disease or non-infectious pneumonia), or who have a history of this and required steroid treatment for it.
- People who still have significant side effects from previous cancer treatments that have not resolved to a mild level.
- People with active inflammatory bowel disease, a blocked bowel, severe ulcers, a hole in the bowel, an abdominal abscess, or active bleeding in the digestive system.
- People who have needed ongoing medical treatment for an autoimmune disease (where the immune system attacks the body) within the past two years.
- People with active tuberculosis, active hepatitis B, or active hepatitis C.
- People who have tested positive for HIV or have a history of AIDS, or who have an active syphilis infection.
- People who are known to be allergic to the study drug or any of its ingredients, or who have had a severe allergic reaction to similar biological medicines.
- People who are pregnant or breastfeeding.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 86+18622221183
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
Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 September 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.