First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
NCT01609556 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2021-02-17
Summary
The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
Conditions
Interventions
- DRUG
-
Mirvetuximab soravtansine
Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.
Sponsors & Collaborators
-
ImmunoGen, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-28
- Primary Completion
- 2018-03-19
- Completion
- 2018-03-19
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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