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Ovarian Cancer MetastaticPhase 2NCT07311577

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

A Phase 2 study testing RC48+Carboplatin+Bevacizumab in people with Ovarian Cancer Metastatic and Ovarian Cancer Metastatic Recurrent, run by Jiangsu Cancer Institute & Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RC48+Carboplatin+Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesChina
Study dates
1 Jan 2026to 30 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • ≥ 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
  • Hb ≥ 90 g/L
  • WBC ≥ 3 × 10⁹/L
  • ANC ≥ 1.5 × 10⁹/L
  • PLT ≥ 90 × 10⁹/L Biochemistry
  • 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 cannot join

  • 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.
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  • 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:
  • PR interval > 0.24 s or 2nd/3rd-degree AV block.
  • Uncontrolled hypertension (SBP > 150 mmHg or DBP > 90 mmHg).
  • MI, unstable angina or significant arrhythmia < 6 months before enrolment.
  • NYHA class ≥ II congestive heart failure.
  • Serious arrhythmia requiring anti-arrhythmic therapy.
  • ≥ Stage-II peripheral vascular disease (except transient ischaemia < 24 h without permanent deficit and no surgery).
  • 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:
  • HIV positive (HIV-1/2 antibody).
  • Active hepatitis B (HBsAg positive or HBV DNA > 2 000 IU/mL with abnormal LFT).
  • Active hepatitis C (HCV antibody positive or HCV RNA ≥ 10³ copies/mL with abnormal LFT).
  • Active tuberculosis.
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

    xiang xiao Chen, Chief physician, 025 83283348, cxxxxcyd@gmail.com

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

    Xiaoxiang Chen, 13851647229, cxxxxcyd@gmail.com

    Recruiting

Other trials in China

About this study

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:

Read more

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).

Being tested
RC48+Carboplatin+Bevacizumab
Keywords
RC48, HRD-Negative High-Risk Ovarian Cancer, HER2-expressing

What participants receive

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

  • RC48+Carboplatin+BevacizumabDrug

    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).

Study groups in NCT07311577
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: RC48+Carboplatin+Bevacizumab

What is being measured

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

  1. Progression-Free Survival (PFS)

    From enrollment until documented disease progression or death from any cause, whichever occurs first.

    Measured: From enrollment until 16 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Disease Control Rate (DCR) is defined as the proportion of patients who achieve a Best Overall Response of PR or CR .

    Measured: up to 24 weeks

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of patients who achieve a Best Overall Response of PR or CR or SD.

    Measured: up to 24 weeks

  3. overall survival（OS）

    From enrollment until death from any cause.

    Measured: Up to 5 years

  4. Incidents of Adverse Events

    All patients who receive at least one dose of any study drug are included in the safety-analysis set.

    Measured: 30 days after the end of treatment

Timeline

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

  1. First posted31 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07311577
Sponsor's protocol ID
RCVDTYPEC170
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48+Carboplatin+Bevacizumab in people with Ovarian Cancer Metastatic and Ovarian Cancer Metastatic Recurrent, run by Jiangsu Cancer Institute & Hospital at 2 sites in China.

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 20 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From enrollment until 16 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 NCT07311577.

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 31 Dec 2025.

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