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Carboplatin

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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.

RC48+carboplatin±bevacizumab

Hong Zheng, M.D.

Hong Zheng, PhD

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.

This study set up a safety introduction period, during which the first 6 subjects who were initially enrolled in the study will slowly undergo safety monitoring. Each patient received RC48 \[2.5 mg/kg, Q3W\]+carboplatin (AUC5 d1 q3w) ± bevacizumab(7.5-15mg/kg d1 q3w) treatment. The monitoring time window is within 28 days after receiving the study drug treatment for the first time. If ≥ 2 dose limited toxicity (DLT) cases were observed in the first 6 subjects, and after evaluation by the research team, it was found that the toxicity was related to treatment with RC48, the initial dose of RC48 treatment for subsequent enrolled patients was adjusted to 2.0mg/kg, Q3W.

Treatment period: RC48+carboplatin ± bevacizumab, repeated every three weeks for a total of 6 cycles； Maintenance period: RC48± bevacizumab (if combined with bevacizumab during the treatment period, maintain treatment with RC48 in combination with bevacizumab; if not used during the treatment period, maintain treatment with RC48 monotherapy). Maintenance duration: Until disease progression or intolerable toxicity occurs, the longest duration of RC48 is 6 months (8 cycles).

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

PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.

ORR is defined as Investigator-assessed CR + PR, per RECIST 1.1

DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases.

OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.

Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression	NCT06420973	Ovarian Carcino... Fallopian Tube ... Primary Periton...	RC48+carboplati...	18 Years - 75 Years	Peking University Cancer Hospital & Institute
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression	NCT06420973	Ovarian Carcino... Fallopian Tube ... Primary Periton...	RC48+carboplati...	18 Years - 75 Years	Peking University Cancer Hospital & Institute

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