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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events

Outcome Time Frame:

Approximately 36 Months

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14247

NCT ID:

NCT01288989

Start Date:

March 2011

Completion Date:

December 2015

Related Keywords:

  • Neoplasms
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

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.Manhassaet, New York  
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  46227
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.Springfield, Massachusetts