Printed from Voxsanity (voxsanity.com.au) — NCT06990503 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Ovarian Cancer Trial, Not Yet Recruiting
NCT06990503
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 is willing to take part and has signed a consent form agreeing to join the trial.
- The person is a woman aged 18 to 75 years old (inclusive).
- The person has been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by tissue or cell testing.
- The person has previously been treated with a platinum-based chemotherapy and their cancer has been confirmed as platinum-resistant (meaning the cancer progressed during platinum treatment or within about 6 months of the last platinum dose); if only one course of platinum treatment was received, at least 4 cycles must have been completed; this resistance must be confirmed by clear scan evidence; after becoming platinum-resistant, the person has received at most one further line of cancer treatment, and is considered suitable for single-agent chemotherapy as the next treatment.
- People whose cancer is known to have high levels of a protein called folate receptor alpha (FRα) must have previously received a treatment called mirvetuximab soravtansine, unless the treating doctor considers it unsuitable or intolerable for that person, or unless that treatment is not approved or available in the local area.
- The cancer has progressed during or after the most recent treatment, or the person experienced side effects that were too difficult to tolerate (with clear documentation).
- The person's tumour must show a protein called HER2 at a level of 1+, 2+, or 3+ as tested by the trial's central laboratory; sufficient tumour tissue (fresh or archived) must be available for this testing.
- The person has at least one measurable area of cancer that meets specific size requirements on a CT scan (confirm with trial site for exact measurements), or a previously treated lesion that has clearly grown since treatment.
- The person has a good general health status, scored as 0 or 1 on a standard performance scale used by doctors (confirm with trial site).
- The person is expected to survive for at least 12 weeks.
- Blood tests taken within 7 days before being assigned to the trial show that the body's major organs are functioning adequately, including: sufficient levels of white blood cells, platelets, and haemoglobin; liver function within acceptable limits; kidney function within acceptable limits; and normal blood clotting measures (specific numbers to be confirmed with trial site; no blood products or growth factors are allowed in the 14 days before these tests).
- Women who could become pregnant must have a negative pregnancy test during screening, must agree to use contraception, and must agree not to donate eggs from the time of signing the consent form until 7 months after the last dose of the trial drug.
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 cancer has been confirmed as a sarcoma type, including mixed tumours that contain sarcoma components.
- People who have untreated or active cancer that has spread to the brain or central nervous system, or who have a history of cancer spreading to the lining around the brain or spine; people whose brain metastases have been fully treated, are stable for at least 4 weeks, no longer need steroid treatment, and whose nervous system has returned to its normal baseline may still be considered.
- People who have previously received certain chemotherapy drugs called topoisomerase I inhibitors (such as irinotecan or topotecan), or antibody-drug treatments (ADCs) that contain these types of drugs, such as Enhertu (DS-8201a) or U3-1402.
- People who have received systemic cancer treatment within the 4 weeks before the trial treatment begins; for small-molecule targeted therapies, the gap must be at least 5 half-lives of that drug or 7 days, whichever is longer.
- People with bothersome, poorly controlled, or moderate-to-severe fluid build-up around the lungs, heart, or abdomen; people who have had fluid drained may be considered if they have been stable for at least 2 weeks after drainage.
- People who completed palliative radiotherapy within 7 days before the first trial dose.
- People with a past or current history of another cancer, except for certain cancers that have been fully treated and cured (such as skin basal cell carcinoma, cervical pre-cancer, breast ductal carcinoma in situ, or papillary thyroid cancer), or other cancers that were fully treated at least 3 years before joining the trial with no signs of return.
- People whose side effects from previous cancer treatment have not improved to a mild level or resolved (with some exceptions such as hair loss, fatigue, and low lymphocyte counts, as assessed by the treating doctor and trial sponsor).
- People with a history of a lung condition called interstitial pneumonia or non-infectious pneumonia that required steroid treatment, or who currently have or are suspected to have these conditions; also people who had a severe (Grade 3 or above) episode of interstitial pneumonia during previous immunotherapy treatment.
- People with active tuberculosis; people who have completed adequate tuberculosis treatment and finished that treatment at least 3 months before joining may be considered.
- People with known lung damage from existing lung conditions, including pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), or restrictive lung disease occurring within 3 months before the first dose.
- People with autoimmune, connective tissue, or inflammatory diseases that affect the lungs (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis), or people who have previously had a lobe or an entire lung surgically removed.
- People with uncontrolled heart conditions, including: moderate-to-severe heart failure or a reduced heart pumping function below 50%; unstable chest pain (angina); a heart attack within the past year; significant irregular heart rhythms requiring treatment; a specific heart electrical measurement (QTcF) above 470 milliseconds; or high blood pressure that cannot be controlled with medication (blood pressure controlled to 160/100 mmHg or below with medication may be acceptable).
- People who have had a blood clot in an artery or vein (such as a stroke or deep vein thrombosis) within 1 month before joining; people with small or catheter-related clots may be considered if the treating doctor judges there is no significant risk.
- People who have experienced a hole or abnormal channel in the gut or urinary tract, or an abdominal abscess, within 3 months before joining; people with a surgically created opening or ureteral stent considered stable by the treating doctor may be considered.
- People who have had a bowel obstruction, or symptoms suggesting one, or who have needed intravenous feeding within 3 months before the trial starts; people who have had surgery to fully resolve an obstruction may be considered; people with a bowel stent still in place at the time of screening are not eligible.
- People who have had a severe infection within 1 month before joining, including infections requiring hospitalisation, bloodstream infections, or severe pneumonia; also people with any active infection currently requiring intravenous antibiotics, or people with an unexplained fever above 38.5°C during screening.
- People with active hepatitis B or active hepatitis C, as determined by specific blood tests during screening (confirm with trial site for exact definitions).
- People with a history of immune system deficiency, a positive HIV test, other inherited or acquired immune conditions, or a history of organ transplant.
- People who have had major surgery (other than diagnostic or biopsy procedures) within 28 days before the first dose; people who have had minor surgical procedures involving tissue damage (such as biopsy, laparoscopy, or drainage) within 7 days before the first dose; or people with wounds that have not properly healed.
- People known to be allergic to any ingredient of the trial drug (SHR-A1811), or who have had a severe allergic reaction to other monoclonal antibody or fusion protein treatments.
- People with uncontrolled mental health conditions, known alcohol or substance misuse or addiction, criminal detention, or other circumstances that may prevent full participation in the trial.
- People with other serious illnesses, including a heart attack or stroke within the past 3 months, or severe liver disease (decompensated cirrhosis).
- People who, in the treating doctor's judgement, have any other condition that could increase risk, interfere with results, or make participation in 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.
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: Qinglei Gao, Tongji Hospital
Phone: +86-27-83662681
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 3
Sponsor
Tongji Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
1 June 2030
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression Free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 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.