A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
Status: | Terminated |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2013 |
End Date: | April 2015 |
A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in
adult patients with advanced EGFR-positive tumors.
adult patients with advanced EGFR-positive tumors.
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
We found this trial at
4
sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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