RecruitingPhase 2NCT06420973

RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression

A Single-arm, Multicenter, Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

54 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called RC48 — a targeted therapy that delivers chemotherapy directly to cancer cells expressing HER2 — for women with ovarian, fallopian tube, or peritoneal cancer that has come back after platinum-based chemotherapy. **You may be eligible if...** - You are a woman aged 18–75 with confirmed ovarian, fallopian tube, or peritoneal cancer - Your cancer has come back after prior platinum-based chemotherapy - You have received 1–4 prior lines of treatment - Your cancer tests positive for HER2 (IHC 1+, 2+, or 3+) - You are in reasonably good health (ECOG 0–1) with measurable cancer on imaging **You may NOT be eligible if...** - You have previously received HER2-targeted therapy - You have very poor overall health or organ function - You are pregnant or breastfeeding - Your cancer is not measurable on imaging 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

RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy.


Locations(1)

Hong Zheng

Beijing, Beijing Municipality, China

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NCT06420973


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