Printed from Voxsanity (voxsanity.com.au) — NCT07545460 — 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
NCT07545460
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 voluntarily sign the consent form and follow the study requirements.
- People who are aged 18 to 75 years old on the day they sign the consent form.
- People who are expected to live for at least 3 months.
- People whose cancer has been confirmed by laboratory testing (from tissue or cell samples) to be epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- People who have previously received a platinum-based chemotherapy treatment and whose cancer has been confirmed to have come back in a way that no longer responds to platinum-based treatment.
- People who have received at least 1 but no more than 3 prior rounds of cancer treatment.
- People who were previously confirmed to have a protein called folate receptor alpha (FRα) on their cancer cells must have already received a treatment called mirvetuximab soravtansine.
- People who are able to provide stored tumour tissue samples collected within the last 3 years, or fresh tissue samples.
- People who have at least one area of cancer that can be measured on scans, according to standard measurement guidelines (RECIST v1.1).
- People whose general physical health and ability to carry out daily activities is rated as 0 or 1 on a standard scale used by doctors (ECOG performance status).
- People whose side effects from previous cancer treatments have mostly resolved to a mild level or better, according to standard medical grading guidelines.
- People who do not have severe heart problems, with the heart pumping at least 50% of its capacity (confirmed by a heart function test).
- People whose liver, kidneys, blood, and other organs are functioning at levels that meet the trial's requirements (confirm with trial site for specific values).
- Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment and must not be breastfeeding; all participants must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
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 who have had surgery, intensive radiotherapy, immunotherapy, or similar treatments within 4 weeks before the first study dose.
- People who have previously received a type of targeted therapy called an antibody-drug conjugate (ADC) that uses a topoisomerase I inhibitor as its active component, or a HER2-targeted ADC therapy.
- People who have had a serious heart or stroke-related condition in the 6 months before screening.
- People who have a current lung disease that severely affects their breathing.
- People who have certain heart rhythm or electrical problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat.
- People who have been diagnosed with another active cancer within 3 years before joining the study.
- People who have had an unstable blood clot requiring active treatment within 6 months before screening.
- People whose high blood pressure is not adequately controlled even with two blood pressure medications.
- People whose blood sugar levels are poorly controlled.
- People who have a history of a lung condition called interstitial lung disease (ILD) that was treated with steroids, or who currently have ILD, or who have had moderate or severe radiation-related lung inflammation.
- People who have cancer that has spread to the brain or spinal cord and is currently active.
- People who have a known allergy to the study drug (BL-M07D1) or any of its ingredients, or to similar antibody-based medicines.
- People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
- People who test positive for HIV, or who have an active hepatitis B or hepatitis C infection.
- People who have had a serious infection within 4 weeks before the first study dose.
- People who have large or symptomatic fluid build-up in body cavities (such as around the lungs or abdomen).
- People who are taking long-term oral steroid medications at a dose greater than 10 mg per day of prednisone (or equivalent) before joining the study.
- People who have a history of serious neurological or psychiatric conditions.
- People who have had a serious wound, ulcer, or bone fracture that has not healed within 4 weeks before signing the consent form.
- People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form.
- People who have bowel blockage, Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea.
- People who have received another unapproved experimental drug or treatment as part of another clinical study within 4 weeks before joining this trial.
- People who have received or plan to receive a live vaccine within 28 days before the first study dose.
- People who, in the opinion of the study doctor, have other serious health conditions, abnormal test results, or other factors that could make participation unsafe, affect the study results, or make them unsuitable for the trial.
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: 15013238943
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
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 December 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free survival (PFS); Overall survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.