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Phase 3 Ovarian Cancer Trial, Not Yet Recruiting
NCT07708753
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
- Women aged 18 or older at the time of signing the consent form.
- People who have been diagnosed through laboratory testing with a specific type of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (high-grade serous carcinoma or grade 2–3 endometrioid carcinoma).
- People who have previously received platinum-based chemotherapy and whose cancer has come back or continued to grow either during that treatment or within 6 months of the last dose, and who have received no more than 1 additional treatment after that point, with no more than 4 treatment lines in total.
- People who have at least one measurable area of cancer outside the brain that can be tracked using standard imaging criteria.
- People whose expected survival is at least 3 months.
- People with a good general health and activity level (rated 0 or 1 on a standard medical scale), with no decline in that rating in the 28 days before joining.
- People whose heart pumping function is at 50% or above, confirmed by a heart scan done within 28 days before joining.
- People whose blood cell counts — including white blood cells, platelets, and red blood cells — meet minimum required levels within 7 days before joining, without having received blood transfusions or blood-boosting medications in the 7 days before the blood test.
- People whose kidney function, liver function, and blood protein levels fall within the required ranges on blood tests taken within 7 days before joining (with slightly different limits allowed for people with certain liver conditions such as Gilbert's syndrome or liver metastases).
- People whose blood clotting levels are within the required range, or, for those already on blood-thinning medication, whose levels are stable and within the treatment target range.
- People whose side effects from previous treatments have largely resolved to mild or baseline levels (with some exceptions such as hair loss, mild nerve-related symptoms, and certain other effects the doctor considers low risk).
- People who have waited a sufficient period of time since their last cancer treatment before starting the study drug (confirm with trial site for specific timeframes).
- People who are willing to provide a previously removed tumour sample or have a new tumour biopsy taken to test for a specific protein called B7-H3, provided there are no medical reasons preventing this.
- Women who could potentially become pregnant must have a negative blood pregnancy test within 7 days before joining, must agree to use highly effective contraception throughout the study and for at least 7 months after the last dose, must not breastfeed during this time, and must not donate eggs or have eggs collected for personal use during this period.
- People who are willing to give written informed consent after fully understanding what the trial involves.
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 continued to grow within 1 month of their last platinum-based chemotherapy (known as platinum-refractory disease).
- People who have previously received any treatment specifically targeting a protein called B7-H3.
- People who have previously been treated with irinotecan, topotecan, any other topoisomerase I inhibitor, or an antibody-drug combination treatment that targets a related enzyme (such as trastuzumab deruxtecan).
- People for whom the treating doctor considers all three of the comparison treatments in this trial (paclitaxel, topotecan, and pegylated liposomal doxorubicin) to be unsuitable.
- People with a history of serious heart or stroke-related conditions, including moderate-to-severe heart failure, a heart attack or unstable chest pain within the past 6 months, or a stroke or related event within the past 6 months.
- People with a certain type of irregular heart rhythm on an ECG (a specific electrical measurement above a set threshold), or a history of serious heart rhythm problems such as certain types of heart block, atrial fibrillation, or ventricular fibrillation (excluding past episodes of atrial fibrillation or flutter that resolved).
- People who are unwilling or unable to stop taking medications known to affect heart rhythm (specifically those that prolong the QT interval).
- People with a current or past history of lung inflammation (interstitial lung disease) that has required steroid treatment, lung scarring, radiation-related lung damage requiring hormones, or who show signs of these conditions on imaging at the time of screening.
- People with a history of certain underlying lung conditions, including a blood clot in the lungs within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or other significant lung damage, or people who require supplemental oxygen.
- People with currently active tuberculosis of the lungs (people who completed tuberculosis treatment at least 3 months before joining may be considered).
- People with any autoimmune, connective tissue, or inflammatory disease affecting the lungs, such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis, either confirmed or suspected at the time of screening.
- People who have had a serious blood clot event requiring treatment within the past 6 months, such as a deep vein thrombosis, arterial clot, or pulmonary embolism (people with certain stable, low-risk clots assessed by the doctor may be considered).
- People with an active, uncontrolled infection currently requiring intravenous antibiotics, antiviral drugs, or antifungal drugs.
- People with a known HIV infection, or a currently active syphilis infection requiring systemic treatment.
- People with active viral hepatitis B or C based on specific blood test results.
- People with spinal cord compression, or active brain or meningeal metastases that are currently causing symptoms or are unstable (people with previously treated brain metastases that have been stable for at least 4 weeks, or untreated brain metastases that cause no symptoms and do not require treatment, may be considered — confirm with trial site).
- People who have been diagnosed with another active cancer in the past 3 years, except for certain fully treated skin cancers, superficial bladder cancer, or carcinomas in situ that have been completely removed and are considered low risk by the doctor.
- People with moderate or severe fluid build-up around the lungs, heart, or in the abdomen (people who have had the fluid drained and have been stable for at least 2 weeks after drainage may be considered).
- People with fistula conditions such as abnormal passages between the genitals, urinary tract, or bowel (people who have had these surgically treated and fully recovered may be considered).
- People with a current bowel obstruction, symptoms suggesting a bowel obstruction, a need for feeding through a vein in the past month, an intestinal stent still in place at screening, bowel bleeding in the past month (except confirmed haemorrhoidal bleeding or a weakly positive stool test), or an abdominal abscess within the past month.
- People who have taken certain medications that strongly affect how the body processes drugs (specifically strong inhibitors or inducers of CYP3A4 and CYP2C8, or inhibitors of OATP1B1/OATP1B3) within 14 days before the first study dose, or who would need to continue taking such medications during the study (confirm with trial site).
- People with a known allergy to the study drug or any of its ingredients.
- People who have previously undergone an autologous or allogeneic stem cell transplant.
- People with a history of serious neurological or psychiatric conditions, including dementia, severe depression, epilepsy, or bipolar disorder.
- People with a history of drug abuse, or any other medical condition that, in the doctor's opinion, may increase safety risks, interfere with participation, or affect the reliability of study results.
- People who have received a live vaccine or are planning to receive one within 28 days before the first study dose.
- People with other serious physical conditions, significant abnormal lab results, or poor likelihood of being able to follow the study requirements, who are considered unsuitable by the treating doctor.
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: 031169085587
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
CSPC Megalith Biopharmaceutical Co.,Ltd.
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 October 2029
Primary endpoints
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.