Printed from Voxsanity (voxsanity.com.au) — NCT07124793 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07124793
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 give written consent and follow the visit schedule and procedures required by the trial.
- People aged 18 to 75 years, of any gender.
- People with a physical functioning score of 0 or 1 on a standard cancer performance scale (meaning they are fully active or have only minor restrictions on activity).
- People with an expected survival of at least 3 months.
- People with locally advanced or metastatic solid tumours confirmed by tissue or cell testing, where surgery is not possible and radical combined radiation and chemotherapy is not suitable.
- For Cohort A (a specific type of lung cancer with an EGFR mutation): People with confirmed unresectable locally advanced or metastatic non-small cell lung cancer, with a specific EGFR gene mutation (ex19del or L858R) found in tumour tissue or blood, who have previously been treated with at least one approved EGFR-targeted therapy and whose cancer has progressed or who could not tolerate it (people with a T790M mutation must have received a third-generation EGFR-targeted therapy); and who have also had their cancer progress or could not tolerate at least one course of platinum-based chemotherapy for advanced or metastatic disease; and whose cancer has progressed or who could not tolerate the most recent anti-cancer treatment.
- For Cohort B (a specific type of ovarian or related cancer): People with confirmed locally advanced unresectable or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; people with a documented BRCA gene mutation who have previously been treated with a PARP inhibitor; people whose tumours show positive folate receptor-alpha (FRα) expression who have previously received mirvetuximab soravtansine or a similar targeted drug therapy, and whose cancer has been confirmed to have progressed; people who have previously received at least one course of platinum-based chemotherapy and experienced disease progression (with specific conditions depending on how many courses of platinum-based chemotherapy were received — confirm details with trial site); and people who have received at least one prior course of systemic anti-cancer treatment (with specific rules about how prior treatment lines are counted — confirm details with trial site).
- People with adequate bone marrow function, including sufficient levels of white blood cells, platelets, and haemoglobin, without having received certain blood-boosting treatments or transfusions in the 14 days before the first dose.
- People with adequate liver function, including acceptable levels of bilirubin, liver enzymes, and albumin (without albumin infusion in the 14 days before the first dose).
- People with adequate kidney function, based on blood creatinine levels or a calculated kidney function measure, and acceptable levels of protein in the urine.
- People with adequate blood clotting function, within specified ranges (people on anticoagulant therapy who meet these ranges may also be eligible — confirm with trial site).
- People who have at least one measurable area of disease based on standard imaging criteria (RECIST v1.1).
- Women of childbearing age who have a negative pregnancy test within 7 days before the first dose (a blood test is required if the urine test is unclear).
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 in Cohort B whose cancer is confirmed by tissue or cell testing to be a sarcoma, mucinous carcinoma, undifferentiated carcinoma, or a combination of these types.
- People in Cohort B whose cancer is confirmed to be a low-grade or borderline tumour, or whose cancer contains these types of cells.
- People who have previously received IL-2 or IL-15 cytokine therapy, except when these were used as part of certain cell therapies or immune treatments for people with weakened immune systems.
- People who have received certain anti-cancer medications or treatments too recently before the first dose, including: small-molecule targeted therapies or oral chemotherapy within 2 weeks or 5 half-lives (whichever is longer); intravenous chemotherapy within 3 weeks; certain Chinese herbal medicines with anti-cancer indications within 2 weeks; nitrosourea-type chemotherapy agents or mitomycin C within 6 weeks; antibody-based anti-cancer therapies within 4 weeks; participation in another medical device or therapeutic clinical trial within 2 weeks; palliative radiotherapy within 2 weeks or radical radiotherapy within 4 weeks; adoptive cell therapy within 8 weeks; or live vaccines within 4 weeks.
- People with active or untreated cancer spread to the brain or the lining of the brain or spinal cord, confirmed by imaging — though people with small, symptom-free brain metastases meeting specific criteria, or people whose brain metastasis symptoms have been stable for at least 4 weeks after treatment and who meet all specified conditions, may still be considered (confirm with trial site).
- People whose tumour is growing into or pressing on important nearby structures such as major blood vessels, the heart, the windpipe, or the oesophagus, or where there is a risk of an abnormal opening forming between the digestive or breathing passages.
- People who have had a serious toxic reaction to immune checkpoint inhibitor treatment in the past that required the treatment to be permanently stopped.
- People who still have side effects from previous anti-cancer treatment that have not recovered to a mild or absent level, with some exceptions such as certain types of hair loss, nerve-related symptoms, low magnesium levels, or other stable conditions the trial doctor considers to pose no safety risk.
- People who have not sufficiently recovered from a previous surgery, or who have had major surgery within 4 weeks before the first dose.
- People with significant heart or blood vessel conditions, including: certain irregular heart rhythms requiring medication; severe electrical conduction problems in the heart; a prolonged QT interval (a heart rhythm measurement) of 480 ms or more; high blood pressure that is not controlled despite standard treatment; a history of inflammation of the heart muscle; currently requiring treatment for heart failure; a reduced heart pumping function (below 50%); Class III or IV heart disease according to a standard classification; a heart attack, unstable chest pain, or certain heart procedures within the past 6 months; or a history of arterial blood clots, stroke, or similar events within the past 6 months.
- People with a history of deep vein blood clots, pulmonary embolism, or another serious clotting event within the 3 months before the first dose (certain minor clot types are excluded from this — confirm with trial site).
- People with known active seizures.
- People with lung inflammation (interstitial pneumonia) that requires steroid or other treatment, a history of other significant lung diseases such as pulmonary fibrosis or interstitial lung disease, uncontrolled lung conditions, or imaging findings during screening that suggest such conditions may be present.
- People with a history of significant allergic conditions, asthma, or atopic dermatitis.
- People with fluid build-up around the lungs, in the abdomen, or around the heart that requires drainage or is causing noticeable symptoms.
- People who have had an active autoimmune disease requiring systemic treatment within the 2 years before the first dose — though certain replacement therapies such as thyroid hormone or insulin are not considered systemic treatments for this purpose.
- People who have used immunosuppressive drugs within 14 days before the first dose, with some exceptions including low-dose steroids, inhaled or nasal steroids, or steroids used to prevent reactions to imaging contrast agents.
- People who have had an organ transplant from another person.
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.
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
Phone: 0512-69566088-8095
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
Innovent Biologics (Suzhou) Co. Ltd.
Registry
ClinicalTrials.gov
Start date
31 August 2025
Est. completion
30 September 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.