Disitamab vedotin (RC48) plus carboplatin as first-line treatment for advanced HER2-positive ovarian, fallopian tube, or primary peritoneal cancer

Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment

This trial will test whether combining disitamab vedotin (RC48) with carboplatin works and is safe as a first-line treatment for people with advanced HER2-positive ovarian, fallopian tube, or primary peritoneal cancer who have had initial debulking surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sex: Female
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Disitamab, bevacizumab
• Locations: 1 site (Zhejiang, Zhejiang)
• Trial ID: NCT07285941 on ClinicalTrials.gov

What this trial studies

This Phase 2, single-center interventional trial gives disitamab vedotin (RC48) combined with carboplatin to patients with stage II–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are chemotherapy-naive after initial debulking surgery (R0 or R1). Eligible patients must have HER2 protein expression of IHC 2+ or 3+, ECOG performance status ≤2, and adequate organ function including cardiac, hepatic, renal, and hematologic parameters. The regimen replaces standard paclitaxel with RC48 in first-line therapy and monitors tumor responses and adverse events across treatment cycles. All treatment and follow-up visits are conducted at Zhejiang Cancer Hospital in Zhejiang, China.

Who should consider this trial

Good fit: Ideal candidates are adults with stage II–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer that is HER2 IHC 2+ or 3+, who received first debulking surgery with R0/R1 resection, have not had prior chemotherapy, and have ECOG ≤2 with adequate organ function.

Not a fit: Patients without HER2 overexpression (IHC 0–1+), those who have already received chemotherapy, or those with poor organ function or an expected survival under three months are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, this regimen could improve tumor response and survival for HER2-overexpressing ovarian cancer patients and may avoid some paclitaxel-related toxicities.

How similar studies have performed: Antibody–drug conjugates targeting HER2, including disitamab vedotin, have shown responses in HER2-positive gastric, urothelial, and some breast cancer settings and early signals in ovarian cancer, but using RC48 plus carboplatin as first-line therapy for ovarian cancer is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
* Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
* HER2 expression: IHC 2+ or 3+;
* Had not received chemotherapy before enrollment;
* ECOG PS ≤ 2;
* Expected survival period ≥ 3 months;
* Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula;
* Non-pregnant women;
* Signed a written informed consent form before the trial.

Exclusion Criteria:

* Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
* The subject had central nervous system diseases or brain metastases;
* Had previously experienced grade II or above peripheral neuropathy;
* Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
* Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
* Had known allergies to the study-related drugs or their excipients or was intolerant to them;
* Was participating in other clinical trials at the same time;
* Subjects judged by the researcher to be unsuitable for this study.

Where this trial is running

Zhejiang, Zhejiang

• Zhe Jiang Cancer Hospital — Zhejiang, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Shao

Conditions Ovarian Cancer; HER2