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A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer

Fallopian Tube Cancer Clinical Trial

Official title:
A Single-arm, Phase III Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Advanced High-grade Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer With High Expression of Folate Receptor-α

Clinical Trial Summary

This Phase III single-arm study is to evaluate the efficacy and safety of IMGN853 in Chinese adult patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (hereafter referred to as PROC) with high FRα expression.

Clinical Trial Description

This is a single-arm, phase III clinical trial of IMGN853 in Chinese adult patients with platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high expression of folate receptor-α. The objective of this study is to determine the efficacy of IMGN853 in platinum-resistant ovarian cancer (PROC) patients with high folate receptor alpha (FRα) expression. A total of 35 patients will be enrolled. All patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1, RECIST v1.1) at baseline and be eligible for receiving IMGN853. All patients will be treated with the IMGN853 monotherapy with a dose at adjusted ideal body weight (AIBW) of 6 mg/kg on Day 1 of every 3-week cycle (Q3W). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05622890
Study type Interventional
Source Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Contact Xu Sun, Master
Phone +8613645153601
Email sunxu@eastchinapharm.com
Status Recruiting
Phase Phase 3
Start date August 18, 2022
Completion date December 31, 2023
View Details
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