A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer
NCT05622890 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2022-11-21
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.
Conditions
- Epithelial Ovarian Cancer
- Peritoneal Cancer
- Fallopian Tube Cancer
Interventions
- 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.
Sponsors & Collaborators
-
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-18
- Primary Completion
- 2023-04-30
- Completion
- 2023-12-31
Countries
- China
Study Locations
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