A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

Phase 1

Terminated

• Conditions: EGFR Positive Solid Tumors
• Interventions: Drug: IMGN289

• Registration Number: NCT01963715
• Lead Sponsor: ImmunoGen, Inc.

Brief Summary

This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18 years old at time of consent
• Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
• EGFR-positive tumor expression
• Adequate blood and organ function
• Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
• Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements

Exclusion Criteria

• Other anti-cancer treatment during the study
• Symptomatic brain metastases
• Other clinically significant disease as defined by the protocol
• Chronic skin condition that requires prescribed oral or intravenous treatment
• History of severe rash that required discontinuation of prior EGFR targeted therapy
• Receiving therapeutic doses of warfarin or heparin for anti-coagulation
• Known diagnosis of HIV or active viral hepatitis
• Women who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGFR+ Solid Tumor	IMGN289	EGFR+ Solid Tumor

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 2 years
Area under the plasma concentration versus time curve	Up to 2 years	Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Peak plasma concentration (Cmax) of IMGN289	Up to 2 years	Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Presence of Human Anti Human Antibody and Human Anti Drug Antibody	Up to 2 years	Assess whether participants develop an immune response to IMGN289
Tumor measurements per RECIST 1:1	Up to 2 years	Assess preliminary anti-tumor activity

Trial Locations

Locations (4)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States