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High-grade Serous Ovarian CancerPhase 2KAT-1NCT07920159

Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer

A Phase 2 study testing Suvemcitug in people with High-grade Serous Ovarian Cancer, run by Anhui Provincial Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Patients with advanced high-grade serous ovarian cancer who underwent primary cytoreductive surgery and received adjuvant chemotherapy with paclitaxel plus carboplatin were included. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
High-grade Serous Ovarian Cancer
What is being tested?
Suvemcitug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
No sites listed yet
Study dates
1 Jan 2027to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participate in the study, provide written informed consent, and are able to comply with the study requirements.
  • Histologically confirmed primary high-grade serous ovarian cancer (HGSOC) and receipt of primary cytoreductive surgery.
  • Age ≥18 years.
  • FIGO stage III-IV disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • KELIM value <1.
  • Life expectancy >3 months.
  • Adequate major organ function, as defined by all of the following criteria: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count ≥80 × 10⁹/L; hemoglobin ≥80 g/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × the upper limit of normal (ULN); total bilirubin <1.5 × ULN; and serum creatinine <1.5 × ULN.

Who cannot join

  • Histopathologically confirmed mucinous adenocarcinoma or low-grade serous carcinoma.
  • Known hypersensitivity to any study drug or any of its components.
  • Active infection requiring systemic therapy.
  • A history of severe cardiovascular or cerebrovascular disease, including any of the following:
  • Cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the first dose of study treatment;
  • Corrected QT (QTc) interval ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula;
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  • New York Heart Association (NYHA) functional class >II; or
  • Left ventricular ejection fraction (LVEF) <50%.
  • Active ulcer, gastrointestinal perforation, or intestinal obstruction.
  • Active bleeding or a bleeding tendency.
  • Hypertension that is inadequately controlled despite antihypertensive therapy, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
  • Urine dipstick protein ≥2+ with confirmed 24-hour urinary protein excretion >1.0 g.
  • Active hepatitis, defined as follows:
  • Hepatitis B: positive hepatitis B surface antigen (HBsAg) and HBV DNA ≥500 IU/mL or ≥1,000 copies/mL;
  • Hepatitis C: positive hepatitis C virus (HCV) antibody with an HCV viral load above the upper limit of normal.
  • Diagnosis of any other malignancy within 3 years prior to enrollment, except for carcinoma in situ (e.g., carcinoma in situ of the breast, bladder, or cervix) or basal cell or squamous cell carcinoma of the skin that has been treated with potentially curative therapy.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Positive for human immunodeficiency virus (HIV).
  • Confirmed or suspected symptomatic brain metastases.
  • Any clinical or laboratory abnormality, or any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ying Zhou contact

0551-62283954

caddiezy@ustc.edu.cn

Yuebo Li contact

15255191577

About this study

Official title: A Prospective, Single-Arm, Single-Center Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer Stratified by the CA-125 ELIMination Rate Constant K (KELIM)

Patients with advanced high-grade serous ovarian cancer who underwent primary cytoreductive surgery and received adjuvant chemotherapy with paclitaxel plus carboplatin were included. CA125 levels were dynamically monitored within 100 days post-surgery, and the KELIM value was calculated to identify patients at high risk of recurrence with a KELIM < 1.

Read the detailed description

This is a prospective, single-arm, single-center phase II clinical trial. A total of 180 patients undergoing primary debulking surgery (PDS) with histologically confirmed high-grade serous ovarian cancer (HGSOC) and FIGO stage III-IV will be screened. After surgery, patients will receive standard chemotherapy with paclitaxel or albumin-bound paclitaxel combined with carboplatin (TC). CA125 levels will be dynamically monitored during cycles 1 to 3, and KELIM will be calculated prior to cycle 4. Patients with KELIM < 1 who meet other inclusion/exclusion criteria will be enrolled into the treatment cohort, with a planned enrollment of 76 patients. Enrolled patients will receive intensified therapy with suvastatib at 2 mg/kg every 3 weeks in combination with TC from cycle 4 to 6, followed by maintenance monotherapy with suvastatib. Regular assessments of imaging, CA125, and safety will be conducted, and peripheral blood and tumor tissue samples will be collected. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival (OS) and safety, along with exploratory biomarker analyses. Adverse events will be assessed according to NCI-CTCAE version 5.0. PFS and OS will be analyzed using the Kaplan-Meier method, with 95% confidence intervals calculated.

Being tested
Suvemcitug
Keywords
High-grade serous ovarian cancer, CA125 ELIMination rate constant K, Suvemcitug, Anti-angiogenic therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SuvemcitugDrug

    The enrolled patients received sutilitaxel 2 mg/kg, administered once every 3 weeks, in combination with the Paclitaxel combined with Carboplatin regimen for intensified treatment from Cycle 4 to Cycle 6, and then received sutilitaxel monotherapy for maintenance treatment.

Study groups in NCT07920159
Study groupRoleWhat they receive
Treatment of advanced high-grade serous ovarian cancer with suvisetamab combined with chemotherapyExperimentalFor eligible patients, after the paclitaxel combined with carboplatin regimen, the sutilixta monoclonal antibody was added. After completing a total of 6 cycles of chemotherapy, sutilixta monotherapy was used for maintenance treatment (if CA125 was greater than 35 U/ml after the 6 cycles, an additional 2 cycles of chemotherapy containing sutilixta were required). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was overall survival (OS). The survival benefits of this treatment mode were evaluated.
Receives: Drug: Suvemcitug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Time from definitive surgery to the first documented disease recurrence or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last known progression-free assessment.

    Measured: From the date of definitive surgery to the first documented disease recurrence or death from any cause, whichever occurs first, assessed up to 36 months.

Secondary outcomes (1)

  1. Overall Survival (OS)

    Time from the first administration of study treatment to death from any cause.

    Measured: From the date of first study treatment administration to death from any cause, assessed up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920159
Sponsor's protocol ID
Zhouying-KAT-1
Acronym
KAT-1
Status last verified
Sep 2026
First submitted
26 Oct 2026
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Suvemcitug in people with High-grade Serous Ovarian Cancer, run by Anhui Provincial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Zhou (0551-62283954, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From the date of definitive surgery to the first documented disease recurrence or death from any cause, whichever occurs first, assessed up to 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07920159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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