Overview

This trial is active, not recruiting.

Condition folr-1 positive solid tumors
Treatment imgn853
Phase phase 1
Target folate receptor alpha
Sponsor ImmunoGen, Inc.
Start date May 2012
End date March 2017
Trial size 205 participants
Trial identifier NCT01609556, IMGN853-0401

Summary

The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.

United States Kansas, Massachusetts, Michigan, New York, Ohio, Pennsylvania, and Texas
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
imgn853
Dose escalation study. Dosing on day 1 of every 21 day cycle.

Primary Outcomes

Measure
Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of IMGN853
time frame: During study

Secondary Outcomes

Measure
Evaluate the safety and tolerability of IMGN853
time frame: During the study
Characterize the pharmacokinetics of IMGN853
time frame: During the study
Assess IMGN853 pharmacodynamic activity
time frame: During the study
Characterize the immunogenicity of IMGN853
time frame: During the study
Describe any preliminary evidence of IMGN853 antitumor activity
time frame: During the study

Eligibility Criteria

Male or female participants at least 18 years old.

Criteria for Selection of Patient Population Inclusion Criteria - Patients with advanced solid tumor that is refractory to standard treatment, for which no standard treatment is available, or the patient refuses standard therapy. - ≥ 18 years old at the time of informed consent. - ECOG Performance Status 0 or 1. - Patients must have adequate hematologic and organ function. - Patients must be willing and able to sign the informed consent form, and to follow the study visit schedule and other protocol requirements. - Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug. - Women of childbearing potential must have a negative pregnancy test prior to the first dose of study treatment. Exclusion Criteria - Grade >1 neuropathy - Any active or chronic corneal disorder and Sjogren's syndrome. - Serious concurrent illness: - Any other concomitant anti-cancer treatment. - Women of childbearing potential who are pregnant or breast feeding.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by ImmunoGen, Inc..