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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2011
End Date:July 2015
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

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.

This multicenter study will enroll approximately 40 subjects. The actual sample size will
vary depending on how many subjects are needed to obtain at least 3 complete subjects per
cohort.

IMC-3C5 will initially be administered once every week (Cohorts 1-4) in a dose escalated
manner. The starting dose will be 5mg/kg weekly (Cohort 1). Dose escalation will proceed to
10mg/kg (Cohort 2), 20 mg/kg (Cohort 3), and 30mg/kg (Cohort 4). Based on an analysis of the
safety and pharmacokinetic profile of weekly dosing, subjects may be enrolled sequentially
into 2 every-other-week dose cohorts (Cohorts 5-6, 20mg/kg and 30mg/kg). Intermediate doses
may also be used.

Inclusion Criteria:

1. Subject has histologic or cytologic confirmation of cancer

2. Subject has an advanced solid tumor that is refractory to standard therapy or for
which no standard therapy is available

3. Subject has measurable or nonmeasurable disease according to Response Evaluation
Criteria in Solid Tumors (RECIST) Version 1.1

4. Subject has not received prior chemotherapy or prior treatment with an
investigational agent or device within 28 days prior to enrollment(hormone therapy is
acceptable)

5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1,
or 2

6. Subject has adequate hematologic, hepatic, renal, and coagulation function

7. Subject has a life expectancy greater than 3 months

8. Subject agrees to use adequate contraception during the study period and for 12 weeks
after last dose of investigational agent

Exclusion Criteria:

1. Subject has a known sensitivity to monoclonal antibodies or other therapeutic
proteins, or to agents of similar biologic composition as IMC-3C5

2. Subject has received treatment with any monoclonal antibodies including bevacizumab
within 6 weeks prior to enrollment

3. Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or
has experienced a significant injury within 28 days prior to enrollment

4. Subject 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

5. Subject has known or suspected untreated brain or leptomeningeal metastases

6. Subject has uncontrolled hypertension

7. Subject has received an organ transplant

8. Subject has a serious or nonhealing wound, ulcer, or bone fracture

9. Subject has experienced an arterial or venous thromboembolic event within 6 months
prior to enrollment

10. Subject currently has peripheral edema requiring diuresis or anasarca

11. Subject 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

12. Subject is currently using or has received a thrombolytic agent within 28 days prior
to enrollment

13. Subject is receiving aspirin at a dose higher than 325 mg per day or full-dose
anticoagulation

14. Subject if female, is pregnant or is lactating
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