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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT06724263
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 take part voluntarily and have signed and dated a consent form.
- People who are 18 years of age or older at the time they sign the consent form.
- People who have been diagnosed with an advanced solid tumour cancer (confirmed by tissue or cell testing) that has stopped responding to standard first-line treatment, could not be tolerated, has no standard effective treatment available, or where the person has declined standard treatment — and who have received no more than 4 prior rounds of systemic anti-cancer treatment.
- People with recurrent platinum-resistant epithelial ovarian cancer (including primary peritoneal and/or fallopian tube cancer), confirmed by pathology, where the cancer returned or did not respond within 6 months of the last platinum-based treatment.
- People with triple-negative breast cancer — meaning unresectable locally advanced or metastatic breast cancer confirmed by pathology, where testing shows the tumour is negative for ER, PR, and HER-2 (confirm specific testing thresholds with trial site).
- People with cervical cancer that has been confirmed by pathology as inoperable, locally advanced or metastatic.
- People with small-cell lung cancer confirmed by tissue or cell testing that is inoperable, locally advanced or metastatic.
- People with biliary tract cancer (including gallbladder cancer or cholangiocarcinoma) confirmed by pathology as unresectable, locally advanced or metastatic.
- People with hepatocellular carcinoma (liver cancer, excluding mixed type) confirmed by pathology, at a specific stage of disease (BCLC stage C, or stage B without successful response to surgery or local treatment), with well-preserved liver function (Child-Pugh A), and without severe oesophageal or stomach vein swelling that carries a high bleeding risk (confirm with trial site).
- People with colorectal cancer confirmed by pathology as unresectable, locally advanced or metastatic.
- People with non-squamous non-small cell lung cancer confirmed by pathology as unresectable, locally advanced or metastatic, and without a small cell lung cancer component.
- People who are willing to attend all required visits and follow all study procedures.
- People with a general health and activity level rated at 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work).
- People with an expected survival of more than 3 months.
- People who have at least one measurable area of cancer (outside any previously treated radiation fields) that can be seen on CT or MRI scan, meeting specific measurement criteria (RECIST v1.1).
- People with adequate blood cell counts, without having needed blood transfusions, growth factor injections, or corrective medications in the 2 weeks before screening (specific blood count thresholds apply — confirm with trial site).
- People with liver function test results within acceptable ranges (specific thresholds apply, with different limits for those who have cancer that has spread to the liver — confirm with trial site).
- People with adequate kidney function, based on blood creatinine levels or a calculated kidney clearance rate, and with low levels of protein in the urine (confirm specific thresholds with trial site).
- People with adequate blood clotting function within acceptable ranges (confirm specific thresholds with trial site).
- Women of childbearing potential who are not breastfeeding, agree to use highly effective contraception from signing the consent form through to 3 months after the last dose, and who have a negative blood pregnancy test within 7 days before joining the trial.
- Women who cannot become pregnant — either due to surgical sterilisation (removal of both ovaries, both fallopian tubes, or the uterus) or because they have been post-menopausal for 12 or more months before screening (not due to cancer treatment).
- Men whose female partners could become pregnant must agree to use highly effective contraception from signing the consent form through to 3 months after the last dose.
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 previously been treated with anti-PD-1, anti-PD-L1, or similar immune checkpoint therapies targeting PD-(L)1.
- People who have previously been treated with large-molecule VEGF/VEGFR-blocking drugs such as bevacizumab or ramucirumab.
- People with a known serious allergy to the study drug or its ingredients, or who have had a severe allergic reaction to similar large-molecule protein drugs, monoclonal antibodies, or bispecific antibodies in the past.
- Women who are pregnant or currently breastfeeding.
- People who have had major surgery within 4 weeks before the first study dose, or who have major surgery planned during the study period; or (for liver cancer patients) people who have had local liver treatments such as chemoembolisation, radiation, or ablation within 4 weeks before the first dose.
- People who still have side effects from previous cancer treatment that have not recovered to a mild or resolved level (with the exception of hair loss or other issues the doctor considers to carry no safety risk).
- People with active or uncontrolled cancer spread to the brain or spinal cord, or cancer affecting the membranes around the brain — unless symptoms and scans have been stable for at least 4 weeks before the first dose.
- People with fluid build-up around the lungs, heart, or abdomen that requires repeated draining.
- People whose scans show the tumour is wrapping around major blood vessels, or shows significant breakdown or cavity formation that the investigator judges poses a bleeding risk; or people diagnosed with central lung cancer or tumours near the lung's main airways with a risk of bleeding.
- People with a known history of HIV infection or AIDS-related illness.
- People who test positive for active hepatitis B (with detectable virus levels above normal), active hepatitis C (with detectable virus levels above normal), or known active syphilis infection.
- People with an active bacterial, viral, fungal, or other infection (such as mycoplasma or parasites) requiring systemic treatment within 4 weeks before the first dose.
- People with significant heart or blood vessel disease, including serious abnormal heart rhythms requiring treatment, a heart attack or severe chest pain within the past 6 months, moderate-to-severe heart failure, a heart pumping function below 50%, poorly controlled high blood pressure, a history of hypertensive crisis or hypertensive brain injury, or significant large blood vessel disease such as an aortic aneurysm requiring surgery.
- People with blood clotting problems, bleeding disorders, unhealed wounds or fractures, active stomach or bowel ulcers, gastrointestinal bleeding, bowel obstruction, ulcerative colitis, oesophageal or stomach vein swelling, or gastrointestinal perforation within the past 6 months.
- People who have had lung bleeding or coughing up blood (2.5 mL or more per day) within 4 weeks before the first dose.
- People who have had a biopsy or other minor procedure (other than placement of a vascular access device) within 7 days before the first dose.
- People who have had a blood clot in an artery or vein, a stroke, or a mini-stroke (TIA) within 6 months before the first dose.
- People who are on unstable anticoagulant or clot-dissolving therapy within 14 days before the first dose.
- People who have been regularly taking high-dose aspirin (more than 325 mg per day), anti-inflammatory drugs that affect platelet function, or certain blood-thinning medications (such as clopidogrel, ticlopidine, dipyridamole, or cilostazol) within 14 days before the first dose.
- People with diabetes that is not stably controlled with medication, or thyroid conditions (such as an overactive thyroid) that are not stably controlled with medication.
- People with current or previous idiopathic pulmonary fibrosis or idiopathic lung inflammation; current acute lung disease, interstitial lung disease, or pneumonia (other than localised radiation-related lung inflammation); lung scarring; severe breathing difficulty; lung insufficiency; or a requirement for continuous oxygen.
- People with active autoimmune diseases, or a history of autoimmune conditions requiring systemic treatment within the 2 years before screening — including conditions such as myasthenia gravis, autoimmune hepatitis, lupus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or glomerulonephritis (exceptions include hypothyroidism managed with hormone replacement alone, skin conditions not requiring systemic treatment such as vitiligo or psoriasis, or controlled coeliac disease).
- People who have been taking systemic corticosteroids at doses above the equivalent of 10 mg of prednisone per day, or other immune-suppressing medicines, within 14 days before the first dose (exceptions include topical, eye, joint, nasal, or inhaled steroids; short-term preventive steroid use of 7 days or less; or steroids used for non-autoimmune conditions).
- People who have received systemic anti-cancer therapy (including biological agents) within 4 weeks before the first dose; chemotherapy or hormonal anti-cancer therapy within 2 weeks; non-specific immune-modulating treatments (such as interleukin, interferon, thymosin, or similar) within 2 weeks; or Chinese herbal or patent medicines with anti-cancer indications within 1 week before the first dose.
- People who have previously had an organ transplant or bone marrow/stem cell transplant.
- People who have been diagnosed with another cancer within the past 5 years, except for certain completely cured cancers treated with successful surgery (such as basal cell skin cancer, squamous cell skin cancer, cervical carcinoma in situ, or papillary thyroid cancer).
- People who have received a live (attenuated) vaccine within 4 weeks before screening, or who plan to receive one during the study.
- People who participated in another clinical trial and received an experimental treatment within 4 weeks before the first dose.
- People with a history of alcohol or drug misuse within the 12 months before the first dose.
- People with a known psychiatric condition that could affect their ability to follow the trial requirements.
- People with other serious health conditions, abnormal test results, or other circumstances that the investigator considers makes participation in this study unsuitable.
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: +8615010891603
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
Tasly Biopharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
1 August 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 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.