A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube… (NCT07708753) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers
460 participantsStarted 2026-07-01
Plain-language summary
This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female participants aged ≥ 18 years (as of the date of signed informed consent).
. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a histologic subtype of high-grade serous carcinoma or G2-G3 endometrioid carcinoma.
. Participants with prior platinum-based therapy and confirmed platinum-resistant recurrent disease, defined as disease progression or recurrence during platinum-based chemotherapy or within 6 months (183 days) after the last dose of platinum-based chemotherapy. No more than 1 line of systemic therapy following platinum-resistant recurrence, and a total number of treatment lines not exceeding 4 lines.
. At least one evaluable extracranial lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
. Expected survival of the participant is ≥ 3 months.
. ECOG performance status 0-1, with no deterioration in ECOG score within 28 days prior to enrollment.
. LVEF ≥ 50% as demonstrated by ECHO or MUGA obtained within 28 days before enrollment.
. Major organ function must meet the following criteria within 7 days prior to enrollment:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Timeframe: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 16 months.
. Patients with platinum-refractory disease (progression within 1 month after the last platinum-containing therapy).
. Prior treatment with B7H3-targeted therapy.
. Prior treatment with irinotecan, topotecan, any other topoisomerase I inhibitor (including investigational TOP1 inhibitors), or topoisomerase inhibitor-antibody drug conjugate (e.g., trastuzumab deruxtecan, etc.).
. Patients for whom paclitaxel, topotecan, and pegylated liposomal doxorubicin (as listed in the control group) are all considered inappropriate by the investigator.
. History of severe cardiac or cerebrovascular disease, including but not limited to: heart failure ≥ New York Heart Association (NYHA) Class 2; acute coronary syndrome (e.g., myocardial infarction, unstable angina, etc.) within 6 months prior to screening; acute cerebrovascular disease (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) within 6 months prior to screening.
. Mean corrected QT interval using the Fridericia formula (QTcF) \> 470 milliseconds (ms) based on the results of three 12-lead electrocardiogram (ECG) examinations; history of serious cardiac arrhythmia (e.g., complete left bundle branch block, third-degree atrioventricular block, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter, etc.), excluding transient atrial fibrillation and atrial flutter.
. Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.
. A history of or current interstitial lung disease (ILD) requiring glucocorticoid treatment, non-infectious interstitial pneumonia, pulmonary fibrosis, and radiation pneumonitis requiring hormone treatment, or suspected of having such diseases by imaging examination at the time of screening.