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

Lilly

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Biological: IMC-3C5

Study type

Interventional

Funder types

Industry

Identifiers

NCT01288989

CP23-1001 (Other Identifier)

14247

I5G-IE-JBCA (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

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

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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