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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter, Non-Randomized, Single-Arm Phase II Clinical Study

Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter, Non-Randomized, Single-Arm Phase II Clinical Study (NCT07311577) is a Phase 2 interventional studying Ovarian Cancer Metastatic and Ovarian Cancer Metastatic Recurrent, sponsored by Jiangsu Cancer Institute & Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a prospective, multicenter, phase II study designed to evaluate the efficacy and safety of disitamab vedotin combined with platinum plus bevacizumab as first-line therapy for HER2-expressing, HRD-negative high-risk ovarian cancer. Forty-three patients with pathologically confirmed HRD-negative high-risk ovarian cancer will be enrolled. After enrollment, patients will receive disitamab vedotin plus platinum and bevacizumab as first-line and maintenance treatment. First-line phase: Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h ,Bevacizumab 7.5-15 mg/kg intravenously on Day 1 every 21 days over 30-90 min. Maintenance phase: Patients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long). Maintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer Metastatic and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 43 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary participation with written willing to sign a consent form. - Age 18-75 years. - Expected survival ≥ 12 weeks. - Histologically/cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV). - HRD-negative status per local assessment. - High-risk features: macroscopic residual disease after primary cytoreductive surgery for Stage III; prior neoadjuvant chemotherapy; or Stage IV disease. - ≥ 1 RECIST v1.1 measurable lesion (long-axis ≥ 10 mm by spiral CT or ≥ 15 mm short-axis for lymph nodes). - HER2 expression documented locally (IHC 1+, 2+, or 3+); archival or fresh tumor tissue (paraffin block or unstained slides) must be available for central confirmation. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1. - your organs (liver, kidneys, etc.) are working well enough based on blood tests within 14 days before enrolment (no transfusion/haematinics/G-CSF allowed): Haematology 1. Hb ≥ 90 g/L 2. WBC ≥ 3 × 10⁹/L 3. white blood cell count (ANC) at least 1.5 × 10⁹/L 4. PLT ≥ 90 × 10⁹/L Biochemistry a) TBIL ≤ 1.5 × ULN b) ALT/AST/ALP ≤ 3 × ULN (≤ 5 × ULN if liver metastases) c) Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Cockcroft-Gault) - Urinalysis: dipstick proteinuria \< 2+ or 24-h urine protein \< 1 g. - Cardiac function: NYHA class \< III and LVEF ≥ 50 % by echocardiography. - - Women must be surgically sterile, post-menopausal, or use an approved contraceptive method from screening until 6 months after the last dose; serum pregnancy test negative within 7 days of first dose and not breastfeeding. - Able and willing to comply with all study and follow-up procedures. Who Should NOT Join This Trial: - Non-high-risk histologic sub-types of ovarian carcinoma. - cancer that has spread to the brain and/or carcinomatous meningitis. - - Requirement for parenteral hydration/nutrition OR clinical/radiologic evidence of partial bowel obstruction or perforation. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Voluntary participation with written informed consent. * Age 18-75 years. * Expected survival ≥ 12 weeks. * Histologically/cytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV). * HRD-negative status per local assessment. * High-risk features: macroscopic residual disease after primary cytoreductive surgery for Stage III; prior neoadjuvant chemotherapy; or Stage IV disease. * ≥ 1 RECIST v1.1 measurable lesion (long-axis ≥ 10 mm by spiral CT or ≥ 15 mm short-axis for lymph nodes). * HER2 expression documented locally (IHC 1+, 2+, or 3+); archival or fresh tumor tissue (paraffin block or unstained slides) must be available for central confirmation. * ECOG performance status 0-1. * Adequate organ function within 14 days before enrolment (no transfusion/haematinics/G-CSF allowed): Haematology 1. Hb ≥ 90 g/L 2. WBC ≥ 3 × 10⁹/L 3. ANC ≥ 1.5 × 10⁹/L 4. PLT ≥ 90 × 10⁹/L Biochemistry a) TBIL ≤ 1.5 × ULN b) ALT/AST/ALP ≤ 3 × ULN (≤ 5 × ULN if liver metastases) c) Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Cockcroft-Gault) * Urinalysis: dipstick proteinuria \< 2+ or 24-h urine protein \< 1 g. * Cardiac function: NYHA class \< III and LVEF ≥ 50 % by echocardiography. - * Women must be surgically sterile, post-menopausal, or use an approved contraceptive method from screening until 6 months after the last dose; serum pregnancy test negative within 7 days of first dose and not breastfeeding. * Able and willing to comply with all study and follow-up procedures. Exclusion Criteria: * Non-high-risk histologic sub-types of ovarian carcinoma. * CNS metastases and/or carcinomatous meningitis. - * Requirement for parenteral hydration/nutrition OR clinical/radiologic evidence of partial bowel obstruction or perforation. * ≥ Grade-2 peripheral neuropathy. - * Active bleeding or high bleeding-risk conditions (e.g., known coagulopathy, tumour encasing major vessels). * Interval between cytoreductive surgery and first bevacizumab dose \< 28 days. * Concurrent malignancy or history of another primary malignancy within 5 years (except adequately treated in-situ cervix cancer, basal- or squamous-cell skin cancer). * Major surgery within 4 weeks before first study dose and not fully recovered. * Symptomatic or medically-requiring large-volume pleural effusion or ascites. - Live-attenuated vaccine within 30 days before first dose or planned during study. * Significant arterial/venous thrombo-embolic or cerebro-cardiovascular event within 12 months before screening (e.g., DVT, PE, cerebral infarction, intracranial haemorrhage, MI); asymptomatic calf-muscle DVT not needing intervention or lacunar infarct without sequelae are allowed. * Uncontrolled systemic diseases judged by investigator: diabetes, liver cirrhosis Child-Pugh B/C, interstitial pneumonitis, severe COPD, etc. * Clinically-relevant cardiovascular disorders: 1. PR interval \> 0.24 s or 2nd/3rd-degree AV block. 2. Uncontrolled hypertension (SBP \> 150 mmHg or DBP \> 90 mmHg). 3. MI, unstable angina or significant arrhythmia \< 6 months before enrolment. 4. NYHA class ≥ II congestive heart failure. 5. Serious arrhythmia requiring anti-arrhythmic therapy. 6. ≥ Stage-II peripheral vascular disease (except transient ischaemia \< 24 h without permanent deficit and no surgery). 7. Cerebrovascular accident within 6 months. * Severe infection within 4 weeks before first dose (IV antibiotics/antifungals/ antivirals required) or unexplained fever \> 38.5 °C during screening; major surgery within 3 weeks. * Active autoimmune or immunodeficiency disorders (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, RA, IBD, hypophysitis, vasculitis, nephritis). Exceptions: stable hypothyroidism on replacement, type-1 diabetes well controlled with insulin. * Autoimmune disease requiring systemic immunosuppressive/immunomodulatory therapy within 2 years before first dose (stable replacement therapy with thyroxine, insulin or physiological corticosteroids permitted). * Active or poorly controlled infection, including: 1. HIV positive (HIV-1/2 antibody). 2. Active hepatitis B (HBsAg positive or HBV DNA \> 2 000 IU/mL with abnormal LFT). 3. Active hepatitis C (HCV antibody positive or HCV RNA ≥ 10³ copies/mL with abnormal LFT). 4. Active tuberculosis. 5. Other uncontrolled infection \> CTCAE v5.0 grade 2. * History of other malignancy within 5 years (except adequately treated in-situ cervical cancer or basal/squamous-cell skin cancer). - * Concurrent participation in another interventional clinical trial or investigational agent/device within 4 weeks before first dose. - * Known hypersensitivity or intolerance to study drugs or their excipients. - * History of substance abuse that cannot be abstained from, or any psychiatric disorder that may interfere with compliance. Any other condition that, in the investigator's opinion, could increase risk or preclude safe completion of the protocol.

Treatments Being Tested

DRUG

RC48+Carboplatin+Bevacizumab

First-line phase:Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h; Bevacizumab 7.5-15 mg/kg intravenously on Day 1 every 21 days over 30-90 min. Maintenance phase:Patients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long). Maintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07311577), the sponsor (Jiangsu Cancer Institute & Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07311577 clinical trial studying?

This is a prospective, multicenter, phase II study designed to evaluate the efficacy and safety of disitamab vedotin combined with platinum plus bevacizumab as first-line therapy for HER2-expressing, HRD-negative high-risk ovarian cancer. Forty-three patients with pathologically confirmed HRD-negative high-risk ovarian cancer will be enrolled. After enrollment, patients will receive disitamab vedotin plus platinum and bevacizumab as first-line and maintenance treatment. First-line phase: Carboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h ,Bevacizumab 7.5-15 mg/kg intravenously o… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07311577?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07311577?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07311577. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07311577. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.