NCT05622890

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Epithelial Ovarian Cancer
• Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Mirvetuximab Soravtansine	Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Timeline

• Start date: 2022-08-18
• Primary completion: 2023-04-30
• Completion: 2023-12-31
• First posted: 2022-11-21
• Last updated: 2022-11-21

Locations

28 sites across 1 country: China