NCT01609556

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

A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: ImmunoGen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.

Detailed description

The study consists of a dose-escalation phase that will evaluate 2 dosing schedules (Schedule A and Schedule B) of mirvetuximab soravtansine and up to 5 dose-expansion groups at the maximum tolerated dose (MTD). The first 4 escalation cohorts will be single participant cohorts. Subsequent escalation cohorts will use a standard 3+3 design, with each cohort consisting of 3 or 4 to 6 participants. Data were collected and analysed for the escalation and expansion groups by dose schedule and not by individual dose.

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Mirvetuximab soravtansine	Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.

Timeline

• Start date: 2012-06-28
• Primary completion: 2018-03-19
• Completion: 2018-03-19
• First posted: 2012-06-01
• Last updated: 2021-02-17
• Results posted: 2021-02-17

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study