RecruitingPhase 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

Sponsor

Jiangsu Cancer Institute & Hospital

Enrollment

43 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Metastatic Ovarian Cancer Metastatic Recurrent

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. 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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of disitamab vedotin (a targeted antibody-drug treatment), platinum-based chemotherapy, and bevacizumab (a drug that blocks tumour blood supply) as initial treatment and ongoing maintenance therapy for a high-risk form of advanced ovarian cancer that is HER2-positive and lacks a DNA repair defect (HRD-negative). **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced ovarian cancer (Stage III or IV) - Your tumour is HRD-negative (lacks a specific type of DNA repair problem) - Your tumour is classified as high-risk (residual disease after surgery, Stage IV, or you received chemotherapy before surgery) - You have at least one measurable tumour on scans **You may NOT be eligible if...** - Your tumour is HRD-positive - Your cancer is early stage - You have had prior chemotherapy or targeted therapy for ovarian cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC48+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).