Printed from Voxsanity (voxsanity.com.au) — NCT06990516 — 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
NCT06990516
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 join the study, sign a consent form, follow the study requirements, and attend follow-up visits.
- Women aged 18 to 75 years old (inclusive) at the time of signing the consent form.
- People who have been diagnosed through tissue or cell testing with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not including mucinous carcinoma).
- People who have previously received 1 to 3 rounds of platinum-based chemotherapy and whose cancer has come back or worsened at least 6 months (183 days) after finishing the last platinum-based treatment, with evidence of this beyond a raised CA-125 blood marker alone.
- People who have a confirmed BRCA1 or BRCA2 gene mutation (in tumour or blood) or who have tested positive for homologous recombination deficiency (HRD), and who have previously been treated with a PARP inhibitor medication (confirm with trial site if unsure about these terms).
- People who are able to provide enough tumour tissue (fresh or archived) for HER2 testing at a central laboratory — the test result does not affect whether someone can join.
- People who have at least one measurable area of cancer that meets specific size requirements on a CT scan, as defined by standard measurement guidelines called RECIST v1.1.
- People with a general health and activity level rated 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
- People with an expected survival of at least 12 weeks.
- People whose organ function results, taken without blood or cytokine correction treatment in the 14 days before testing, meet all of the following: a neutrophil count of at least 1.5×10⁹/L; a platelet count of at least 100×10⁹/L; haemoglobin of at least 90 g/L; serum albumin of at least 30 g/L; total bilirubin no more than 1.5 times the upper limit of normal; blood clotting times (APTT, INR, and PT) within acceptable ranges; liver enzyme levels (ALT and/or AST) within acceptable ranges (with a higher allowance for people with liver metastases); kidney function within acceptable ranges based on creatinine or creatinine clearance; a heart rhythm measurement (QTc) of no more than 470 milliseconds; a heart pumping function (LVEF) of at least 50% measured within 28 days before starting the study drug; and urine protein below a certain threshold.
- Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the study drug, must not be breastfeeding, and must agree to use contraception from signing the consent form until 7 months after the last dose of the study 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 with untreated or active cancer spread to the brain or central nervous system, or a history of cancer spreading to the lining around the brain or spinal cord — though people whose brain metastases have been fully treated, are stable for at least 4 weeks, and no longer need steroid treatment may be considered.
- People with a current or past history of another cancer, except for certain cancers that have been fully treated and cured for at least 3 years with no signs of return, or specific low-risk conditions such as basal cell skin cancer, certain cervical or breast pre-cancers, or papillary thyroid cancer.
- People with significant or poorly controlled fluid build-up around the lungs, heart, or abdomen — though people who have had the fluid drained and have been stable for at least 2 weeks after drainage may be considered.
- People with a history of lung inflammation (such as from radiation) that required steroid treatment, or who currently have or are suspected to have lung inflammation or other active lung conditions, or who had severe asthma, severe COPD, or restrictive lung disease within 6 months before starting the study drug.
- People with active tuberculosis — though people who completed adequate tuberculosis treatment and stopped that treatment at least 3 months before the study drug begins may be considered.
- People with high blood pressure that cannot be controlled with medication (systolic at or above 140 mmHg or diastolic at or above 90 mmHg), or who have previously had a hypertensive crisis or hypertensive encephalopathy.
- People with serious or uncontrolled heart conditions, such as unstable angina, significant heart failure (NYHA class II–IV), a heart attack within the past 6 months, or unstable angina or irregular heart rhythm within the past month.
- People who have had a blood clot in an artery or vein (such as stroke, deep vein thrombosis, or pulmonary embolism) within 6 months before starting the study drug — though certain minor clots judged low-risk by the treating doctor may not exclude someone.
- People who have had a significant bleeding event in the month before starting the study drug, including coughing up blood, vaginal bleeding, or gastrointestinal bleeding, or who are found to have signs of bleeding risk at screening.
- People with a known tendency to bleed or clot abnormally, or who have used certain blood-thinning or anti-platelet medications (such as aspirin above 325 mg/day, clopidogrel, or ticagrelor) within 14 days before starting the study drug, or who have used anticoagulant therapy for treatment purposes within 2 weeks before starting the study drug (low-dose preventive aspirin and low-dose preventive heparin are allowed).
- People who have had a hole or abnormal passage (fistula) in the gastrointestinal tract, airway, or urinary tract, or an abdominal abscess, within 3 months before starting the study drug, or who are expected to develop these — though people with certain stable surgical connections or stents may be considered after doctor review.
- People who have had a bowel blockage or symptoms of a bowel blockage within 6 months before starting the study drug, unless the blockage was fully resolved by surgery — or people who still have an intestinal stent in place at the time of screening.
- People who have had a serious infection in the month before starting the study drug, including infections requiring hospitalisation or severe pneumonia, or who have an active infection requiring intravenous antibiotics, or an unexplained fever above 38.5°C during screening.
- People with a history of immune system deficiency, a positive HIV test, a history of organ transplant, or active hepatitis B or hepatitis C infection as defined by specific test thresholds.
- People who have recently completed certain anti-cancer treatments and have not waited long enough before starting the study drug — the required waiting period varies depending on the type of treatment received (confirm with trial site for specific timeframes).
- People who have previously received anti-HER2 treatment (such as a HER2 antibody-drug conjugate), or any antibody-drug conjugate containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor drug such as irinotecan or topotecan.
- People who are expected to need other systemic cancer treatments during the study, or who plan to have additional cancer-reducing surgery.
- People who still have side effects from previous cancer treatment that have not improved to a mild level (Grade 1 or below on a standard medical scale), with some exceptions such as hair loss or fatigue (confirm with trial site).
- People who are known to be allergic to any component of the study drug SHR-A1811 or to any platinum-containing drug.
- People who, in the opinion of the treating doctor, have other conditions or circumstances that could affect the study results or make participation unsuitable, such as serious illness, substance misuse, or other significant medical or mental health concerns.
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
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 2
Sponsor
Tongji Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
1 June 2030
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate (ORR):
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.