A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
1 other identifier
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2013
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 2, 2015
September 1, 2015
1.5 years
October 9, 2013
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with dose limiting toxicities
Up to 2 years
Secondary Outcomes (5)
Number of participants with adverse events
Up to 2 years
Area under the plasma concentration versus time curve
Up to 2 years
Peak plasma concentration (Cmax) of IMGN289
Up to 2 years
Presence of Human Anti Human Antibody and Human Anti Drug Antibody
Up to 2 years
Tumor measurements per RECIST 1:1
Up to 2 years
Study Arms (1)
EGFR+ Solid Tumor
EXPERIMENTALEGFR+ Solid Tumor
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ImmunoGen, Inc.lead
Study Sites (4)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrea Vergara-Silva, MD
ImmunoGen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 16, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 2, 2015
Record last verified: 2015-09