Printed from Voxsanity (voxsanity.com.au) — NCT06202313 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06202313
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 who are able to understand the study and sign a written consent form before any study procedures begin.
- People who are aged between 18 and 75 years old (inclusive) at the time of signing the consent form, of any gender.
- People who have a physical fitness score of 0 or 1 on the ECOG scale, which means they are either fully active or have mild restrictions on physically demanding activity (confirm with trial site).
- People whose life expectancy is 3 months or more.
- People who have been confirmed by laboratory testing to have triple negative breast cancer that has come back or spread and cannot be cured.
- People who have received no more than 2 rounds of treatment for their returned or spread cancer, meeting specific criteria about which chemotherapy drugs they received and when (confirm with trial site for the exact treatment history requirements).
- People who have at least one measurable tumour as defined by standard imaging criteria, and who agree to provide tumour tissue samples (either archived or freshly collected) for testing.
- People whose last treatment was completed at least 2 weeks ago (if it was a targeted therapy such as Olaparib) or at least 4 weeks ago (if it was chemotherapy).
- People whose blood test results show adequate bone marrow function: neutrophil count at least 1.5 × 10⁹/L, platelet count at least 100 × 10⁹/L, and haemoglobin at least 9.0 g/dL, without the use of blood transfusions or growth factor support in the 2 weeks before joining.
- People whose kidney function test results are within acceptable limits, including creatinine levels and urine protein levels within specified ranges.
- People whose liver function test results are within acceptable limits, including bilirubin, liver enzymes (AST and ALT), and albumin levels within specified ranges.
- People whose blood clotting test results (INR and APTT) are within acceptable limits.
- Women who are capable of becoming pregnant must have a negative pregnancy blood test within 72 hours before the first dose, and must use an effective form of contraception (such as hormonal contraception, an intrauterine device, or barrier methods) from the start of screening until at least 120 days after the last dose of the study drug — periodic or calendar-based methods are not considered acceptable.
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 whose breast cancer tests positive for HER2 (a specific protein) or hormone receptors.
- People who have previously been treated with PD-1, PD-L1, or CTLA-4 immunotherapy drugs (a type of immune checkpoint treatment).
- People who have received anti-cancer treatments — including chemotherapy, radiation, immunotherapy, targeted therapy, or biological treatments — within the 4 weeks before joining (or 2 weeks for some therapies), or certain traditional Chinese medicines with anti-tumour indications within 2 weeks before joining.
- People who are currently taking part in another clinical trial that involves an active treatment (observational or follow-up-only studies may be acceptable).
- People who have active or untreated cancer that has spread to the brain or surrounding areas, unless specific conditions are met: treatment has been completed, imaging has been stable for at least 4 weeks, and steroid and anti-seizure medications have been stopped for at least 2 weeks.
- People who have fluid build-up in the chest or abdomen that requires draining more than once a month.
- People who have active autoimmune diseases that required systemic treatment within the past 2 years, or that the treating doctor believes may return, with some specific exceptions (such as certain skin conditions, stable thyroid or diabetes conditions managed with hormone or insulin replacement, and fully resolved childhood asthma).
- People who have had certain serious heart or blood vessel events within the past 3 to 6 months, including heart attack, stroke, severe heart failure, poorly controlled abnormal heart rhythm, blood clots in deep veins or lungs, or major vascular conditions such as aortic aneurysm.
- People with a previous history of myocarditis (heart muscle inflammation) or cardiomyopathy (heart muscle disease).
- People whose heart pumping function (left ventricular ejection fraction) is below 50%.
- People who still have unresolved side effects from previous cancer treatments that have not returned to a mild or absent level, with the exception of hair loss or skin pigmentation changes. People who had severe immune-related side effects (grade 3 or above) during previous immunotherapy are not eligible.
- People with irreversible side effects from prior treatment may be considered for inclusion after discussion with the medical supervisor, if those side effects are not expected to worsen with the study drug (confirm with trial site).
- People who have peripheral nerve damage rated as level 2 or above on a standard scale (confirm with trial site).
- People with known interstitial lung disease or non-infectious lung inflammation that is currently causing symptoms or has required steroid treatment, and which the treating doctor believes may affect how side effects from the study treatment are assessed or managed.
- People with known active tuberculosis.
- People who have received systemic antibiotic or antifungal treatment (not including hepatitis B or C antiviral therapy) within the 2 weeks before joining.
- People who have had an organ transplant or a bone marrow/stem cell transplant from a donor.
- People who have active coughing up of blood, active bowel inflammation (diverticulitis), abdominal abscess, or a blockage in the digestive tract.
- People who have had significant bleeding episodes or a clear tendency to bleed within the month before joining, such as stomach bleeding or ulcers.
- People with untreated active hepatitis B (with specific virus levels above defined thresholds), or active hepatitis C (with detectable virus levels in the blood). People with hepatitis B may be eligible if they receive antiviral treatment during the study.
- People with a known history of immune deficiency disorders or a positive HIV test result.
- People with a known active syphilis infection.
- People who require regular systemic steroid treatment at doses greater than 10mg per day of prednisone (or equivalent), or other immune-suppressing drugs, within the 14 days before joining — with some specific exceptions such as low-dose, inhaled, or topical steroids, or steroids used to prevent infusion reactions.
- People who have received a live vaccine within 30 days before joining, or who plan to receive one during the study.
- People with a known history of severe allergic reactions to other monoclonal antibody treatments.
- People with a known allergy or hypersensitivity to cardunizumab, iribrin, or any ingredients in these study drugs.
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: +8618940256668
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Shengjing Hospital
Registry
ClinicalTrials.gov
Start date
10 February 2024
Est. completion
30 December 2025
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.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.