A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.

Key facts

Study ID: NCT01288989
Run by: Eli Lilly and Company
People needed: 44
Starts: 2011-03-01
Expected to finish: 2014-07-01
Last updated by the study team: 2019-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant has histologic or cytologic confirmation of cancer
Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
Participant has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Participant has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable)
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
Participant has adequate hematologic, hepatic, renal, and coagulation function
Participant has a life expectancy greater than 3 months
Participant agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent

You may not qualify if…

Participant has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
Participant has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
Participant has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
Participant has an ongoing or active infection (except as outlined in Exclusion Criterion #11), congestive heart failure, active bleeding or any other serious uncontrolled medical disorder
Participant has known or suspected untreated brain or leptomeningeal metastases
Participant has uncontrolled hypertension
Participant has received an organ transplant
Participant has a serious or nonhealing wound, ulcer, or bone fracture
Participant has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
Participant currently has peripheral edema requiring diuresis or anasarca
Participant has Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), except subjects who have been on a stable antiviral regimen for at least 12 weeks, have a viral load of < 50 copies/mL, and a CD4 count of ≥ 200 cells/mm3
Participant is currently using or has received a thrombolytic agent within 28 days prior to enrollment
Participant is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
Participant if female, is pregnant or is lactating

Where it is running

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Peoria, Illinois, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Indianapolis, Indiana, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — New York, New York, United States

Full record on ClinicalTrials.gov

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