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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07389239
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
- Adults aged 18 or older who have been diagnosed with an advanced (spread or inoperable) solid tumour, confirmed by laboratory testing of a tissue sample.
- People whose tumour tissue (either a stored sample or a new biopsy) shows a specific protein called NY-ESO-1, confirmed by a central laboratory test.
- People with NY-ESO-1-expressing tumours who have already tried at least 2 standard treatments (such as chemotherapy, immunotherapy, or targeted therapy), or who were unable to tolerate or were not eligible for those treatments.
- People with inoperable or metastatic ovarian, primary peritoneal, or fallopian tube cancer who have received platinum-based chemotherapy and whose cancer has stopped responding to it, and who have progressed after a second treatment; or, if the cancer was platinum-sensitive, who have had at least 2 lines of chemotherapy — and who may also have received PARP inhibitors or anti-VEGF therapies such as bevacizumab.
- People with inoperable or metastatic soft tissue sarcoma who have previously received a treatment containing anthracycline or ifosfamide; people with gastrointestinal stromal tumours who have received KIT-targeted therapy if a relevant mutation is present; and people with angiosarcoma who have received taxane-based chemotherapy.
- People with urothelial (bladder) cancer who have received, or declined, at least one platinum-based treatment for advanced disease, and who may also have received a checkpoint inhibitor (anti-PD-1/PD-L1) therapy.
- People with metastatic castration-resistant prostate cancer (where testosterone is kept very low by surgery or medication), who have had at least one chemotherapy for metastatic disease and at least one standard hormonal therapy (such as a 17α lyase inhibitor or second-generation anti-androgen), and whose cancer is continuing to grow.
- People with breast cancer who have received at least one treatment containing anthracycline or taxane (in either early or metastatic settings), unless unable to tolerate it; people with hormone receptor-positive, HER2-negative breast cancer must have also progressed on a CDK 4/6 inhibitor combination; prior hormonal or HER2-targeted therapies are also accepted.
- People with melanoma who have received a PD-1 or PD-L1 inhibitor (with or without a CTLA-4 inhibitor); those with an actionable mutation (such as BRAF) must have also received at least one targeted therapy.
- People with non-small cell lung cancer who have received a PD-1 or PD-L1 inhibitor, and — for those with a low PD-L1 score — also a platinum-based chemotherapy; those with a non-squamous tumour and an actionable mutation (such as EGFR, ALK, or ROS-1) must have received at least one targeted therapy (a checkpoint inhibitor is not required in this group).
- People with other types of advanced solid tumours that express NY-ESO-1 who have received at least one prior treatment.
- People who could not tolerate required prior treatments but have received at least one systemic therapy considered ineffective by their treating doctor.
- People who have tumour tissue available for NY-ESO-1 testing, or who are willing and able to have a fresh tissue biopsy taken.
- People who test positive for a specific immune marker called HLA-A*02:01 (confirmed by a blood test, buccal swab, or existing records).
- People with a life expectancy of more than 3 months, as assessed by a study doctor.
- People who have been informed about other available treatment options.
- People who have at least one measurable tumour lesion, as defined by standard imaging criteria (RECIST 1.1).
- People who have stopped any prior cancer treatments at least 4 weeks before starting the study treatment, and who have fully recovered from any prior radiotherapy before enrolling (radiotherapy to eligible sites must have been completed more than 4 weeks before enrolment).
- People whose serious side effects from prior treatments have resolved to a mild level (Grade 1 or better) before starting the study.
- People with adequate veins suitable for a blood collection procedure called apheresis, and who are willing and able to undergo it.
- Women who could become pregnant must agree to use effective contraception for the duration of the study and for 6 to 12 months after the study drug is no longer detectable in the blood (acceptable methods include condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormonal contraception — a combination of two methods is recommended).
- People with a good general level of physical function, as measured by standard medical scoring (ECOG performance status of 0 or 1).
- People with adequate blood counts and organ function, including sufficient white blood cells, neutrophils, and platelets, and acceptable liver and kidney function, as confirmed by blood tests.
- People who understand the investigational nature of the study and are willing to sign a written informed consent form before any study procedures begin.
- People who can arrange for a caregiver (aged 18 or older) to be available 24 hours a day, 7 days a week, and who can arrange accommodation within a 45-minute drive of the University of Chicago and transportation for a period after leaving hospital (the exact length of time will be determined by the treating doctor).
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 are currently taking part in another clinical trial involving an investigational treatment.
- People with a history of serious allergic reactions to compounds similar to those used in this trial.
- People with serious uncontrolled health conditions, including active infections, moderate-to-severe heart failure (New York Heart Association Class III or IV), a heart pumping function below 45%, a heart attack within the past 6 months, a history of heart muscle inflammation (myocarditis), unstable chest pain, irregular heart rhythms, or mental health or social circumstances that would make it difficult to follow the study requirements.
- People with an active autoimmune disease requiring 10 mg or more per day of prednisone (or an equivalent steroid) or other immune-suppressing treatments.
- People with a history of inflammatory bowel disease, coeliac disease, other chronic gut conditions causing ongoing diarrhoea or bleeding, or a current episode of colitis of any cause.
- People who may need ongoing steroid treatment, or who have received systemic steroids in the 4 weeks before enrolment (inhaled or topical steroids at standard doses, or steroids used as a one-time precaution before a medical procedure such as a CT scan, are allowed).
- People with currently active brain metastases (cancer that has spread to the brain); people whose brain metastases were previously treated successfully with surgery or radiation and are considered under control may still be eligible (confirm with trial site).
- People with dementia or significantly impaired mental function that would prevent them from understanding or consenting to the study.
- People who are pregnant or breastfeeding; people with the ability to become pregnant must use effective contraception as outlined in the inclusion criteria, and must have a negative pregnancy test (blood or urine) within 48 hours of starting the pre-treatment chemotherapy.
- People who would not be available for ongoing immune and clinical follow-up assessments.
- People with abnormal lung function test results, specifically a FEV1/FVC ratio below 70% of the expected normal value.
- People whose blood oxygen level is below 90% while breathing normal room air.
- People with a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease).
- People with fluid build-up in the abdomen, around the lungs, or around the heart that has required repeated draining (twice or more within 4 weeks) or continuous draining within the past 2 months.
- People who have had, or are planning, a major surgical procedure within 4 weeks of the first study treatment dose.
- People who have received a live vaccine within 30 days before enrolling.
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: Daniel Olson, University of Chicago
Phone: 1-855-702-8222
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
Registry
ClinicalTrials.gov
Start date
23 June 2026
Est. completion
10 December 2031
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
To evaluate autologous in the number of participants with treatment-related adverse events.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.