New drug cocktail aims to shrink recurrent ovarian tumors
NCT ID NCT07714668
First seen Jul 20, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This phase II trial tests an experimental drug called SYS6041, alone or combined with chemotherapy and other agents, in women whose ovarian cancer has returned. The study evaluates safety, the best dose, and how well the treatments shrink tumors. Participants must have a specific type of ovarian cancer and have had limited prior therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental antibody-drug conjugate called SYS6041, given alone or with chemotherapy (carboplatin, paclitaxel) and/or bevacizumab and/or enlonstobart
- What this could lead to
- If successful, this could point toward a new treatment option for women with recurrent ovarian cancer, potentially improving tumor shrinkage and delaying disease progression.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not confirm benefit. Side effects from the combination therapies could be significant, and the experimental drug may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 171 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Fully understand this clinical trial and voluntarily sign the written informed consent form 2. Age ≥ 18 years old 3. Histologically or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer 4. Cohort A and B:subjects with platinum-sensitive disease who have received ≤2 prior lines of systemic chemotherapy and if have a BRCAm or HRD-positive status must have recieved PARP inhibitor maintenance therapy; Cohort C: subjects with platinum-resistant disease who have received ≤3 prior lines of systemic chemotherapy 5. Disease progression or intolerability with the most recent systemic anti-tumor treatment 6. Adequate organ function with laboratory tests meeting criteria 7. Have measurable disease per RECIST v1.1 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Expected survival ≥ 3 months 10. Subjects of reproductive potential (males and females) must agree to use reliable contraceptive methods with their partner(s) throughout the trial period and for a minimum of 8 months following the last study drug administration Exclusion Criteria: 1. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy 2. History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll) 3. Subjects with active central nervous system (CNS) manifestations during the screening period, CNS metastases requiring corticosteroid therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis. 4. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk) 5. Major surgery within 28 days before randomization/first dose, or planned to undergo systemic or local tumor resection during the study period 6. Subjects who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to randomization/first study drug administration, or who require continuous systemic administration of such agents during the study treatment period 7. History of severe gastrointestinal disease 8. History of severe cardiovascular disease 9. Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) that necessitate frequent drainage or medical intervention within 14 days before randomization/first dose, or requirement for further intervention within 2 weeks after a previous intervention 10. Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia, current non-infectious pneumonia requiring corticosteroid treatment, or suspected ILD/non-infectious pneumonia identified at screening 11. Active bacterial, fungal or viral infection within 14 days before randomization/first dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy) 12. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \> 2000 IU/mL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \> ULN for active hepatitis C 13. History of immunodeficiency or positive HIV antibody test during screening 14. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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- Blood vessel cells in a simple blood test may predict ovarian cancer therapy success
- Can a radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?