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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of IMC-1121B in Patients With Tumors That Have Not Responded to Therapy

NCT00793975

Advanced Solid Tumors

COMPLETED PHASE1

Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available

NCT00768391

Solid Tumors

COMPLETED PHASE1

Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy

NCT00782002

Advanced Solid Tumors

COMPLETED PHASE1

A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available

NCT00785538

Advanced Solid Tumors

COMPLETED PHASE1

A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

NCT01346358

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMC-3C5

Participants receiving IMC-3C5 intravenously

Group Type EXPERIMENTAL

IMC-3C5

Intervention Type BIOLOGICAL

Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IMC-3C5

Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3022856

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant has histologic or cytologic confirmation of cancer
2. Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
3. Participant has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
4. 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)
5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
6. Participant has adequate hematologic, hepatic, renal, and coagulation function
7. Participant has a life expectancy greater than 3 months
8. Participant agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent

Exclusion Criteria

1. Participant has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
2. Participant has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
3. Participant has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
4. 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
5. Participant has known or suspected untreated brain or leptomeningeal metastases
6. Participant has uncontrolled hypertension
7. Participant has received an organ transplant
8. Participant has a serious or nonhealing wound, ulcer, or bone fracture
9. Participant has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
10. Participant currently has peripheral edema requiring diuresis or anasarca
11. 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
12. Participant is currently using or has received a thrombolytic agent within 28 days prior to enrollment
13. Participant is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
14. Participant if female, is pregnant or is lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No