New drug cocktail aims to shrink recurrent ovarian tumors

NCT ID NCT07714668

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 171 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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