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 | Recruiting Phase 2

• 1 other identifier: RCVDTYPEC170
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Ovarian Cancer Metastatic; Ovarian Cancer Metastatic Recurrent

Keywords

RC48; HRD-Negative High-Risk Ovarian Cancer; HER2-expressing

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

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

  From enrollment until 16 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 24 weeks

• Disease Control Rate (DCR)

  up to 24 weeks

• overall survival（OS）

  Up to 5 years

• Incidents of Adverse Events

  30 days after the end of treatment

Study Arms (1)

Arm A

EXPERIMENTAL

Drug: RC48+Carboplatin+Bevacizumab

Interventions

RC48+Carboplatin+Bevacizumab DRUG

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).

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hb ≥ 90 g/L
• WBC ≥ 3 × 10⁹/L
• ANC ≥ 1.5 × 10⁹/L
• PLT ≥ 90 × 10⁹/L Biochemistry

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (2)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (2)