Printed from Voxsanity (voxsanity.com.au) — NCT06574763 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Ovarian Cancer
Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT06574763
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 willing to take part and have signed a consent form agreeing to join the study.
- People aged 18 to 75 years old at the time of signing consent.
- People with an expected survival of at least 12 months.
- People with a good general level of physical functioning (an ECOG performance score of 0 or 1, meaning fully active or able to carry out light work — confirm with trial site if unsure).
- People who weigh more than 30 kg.
- People who are able to understand what the trial involves and are willing to follow all study and follow-up procedures.
- Women who could become pregnant must agree to use effective contraception throughout the study treatment period.
- People who have been newly diagnosed with high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer at an advanced stage (FIGO stage III or IV), confirmed through tissue or cell testing.
- People whose cancer shows a certain level of HER2 protein expression or gene amplification, as detected by specific laboratory tests (IHC 1+ or higher, or ERBB2 gene amplification).
- People whose physical condition makes them unsuitable for immediate surgery, or where imaging or keyhole surgery assessment suggests that complete surgical removal of the cancer is unlikely.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1).
- People whose bone marrow is functioning well enough, shown by blood tests within 28 days before starting treatment: haemoglobin at least 90 g/dL, neutrophil count at least 1.5 × 10⁹/L, and platelet count at least 100 × 10⁹/L.
- People whose liver is functioning within acceptable ranges, as measured by blood tests within 28 days before starting treatment (specific limits depend on whether liver spread is present — confirm with trial site).
- People whose kidneys are functioning within acceptable ranges, as measured by blood tests within 28 days before starting treatment, including acceptable creatinine and urine protein levels.
- People whose blood clotting is within acceptable ranges, as measured within 28 days before starting treatment (with different limits for those already on blood-thinning medication).
- People whose heart function meets a minimum standard, rated below Grade 3 on the New York Heart Association scale (meaning not severely limited by heart symptoms — confirm with trial site if unsure).
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 ovarian cancer is of certain specific types, including endometrioid, clear cell, mucinous, or sarcomatoid tumours, any mixed tumours containing these types, or low-grade/borderline ovarian tumours.
- People with known active cancer spread to the brain or the membranes surrounding the brain or spinal cord.
- People with fluid build-up in the chest, around the heart, or in the abdomen that cannot be controlled by drainage or other treatments.
- People with a severe, currently active infection.
- People with a history of multiple sclerosis or other diseases that damage the protective coating of nerves, or Lambert-Eaton syndrome (a nerve-muscle condition sometimes linked to cancer).
- People with serious heart disease, including a heart attack within the 6 months before starting the trial, unstable chest pain (angina), uncontrolled heart failure, uncontrolled high blood pressure (Grade 3 or higher), or uncontrolled irregular heartbeat.
- People who have had a stroke, mini-stroke (TIA), or bleeding in the brain within 6 months before joining the trial.
- People whose heart tracing (ECG) shows clinically significant abnormal results.
- People with a history of a currently active non-infectious lung condition, such as pulmonary fibrosis, interstitial pneumonia, or other serious lung diseases.
- People with a history of severe liver scarring (cirrhosis, Child-Pugh class C).
- People with a history of a hole or tear in the bowel wall, a fistula in the abdominal wall, or active bowel bleeding within 6 months before joining the trial.
- People with a bleeding disorder or significant problems with blood clotting (when not caused by blood-thinning medication).
- People who have had major surgery within 4 weeks before joining the trial (except for exploratory procedures carried out at other hospitals).
- People with wounds that are not healing, active ulcers, or bone fractures.
- People with a history of another type of cancer, except for cancers that carry very little risk of spreading or causing death (confirm with trial site).
- People who have previously been treated with Vedicimab or any other HER2-targeted therapy.
- People who have already received any anti-cancer treatment for ovarian cancer, including chemotherapy, immunotherapy, or targeted therapy (hormone therapy or bone-strengthening medications taken for non-cancer reasons may be acceptable — confirm with trial site).
- People with a known allergy or sensitivity to monoclonal antibody therapies, MMAE-type drugs, or any ingredient in the study drug.
- People who are pregnant or breastfeeding.
- People whom the trial doctor believes have other serious health conditions that would make joining the trial inappropriate.
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: 13602859866
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
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2024
Est. completion
1 September 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.
Primary endpoints
Completed Resection Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 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.