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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/25/2018
Start Date:June 2011
End Date:May 31, 2018

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Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

A dose escalation study to establish the safety profile and characterize the pharmacokinetic
profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to
standard therapy or for which no standard therapy is available.


Inclusion Criteria:

- Subject has histologic or cytologic confirmation of advanced solid tumors that is
refractory to standard therapy or for which no standard therapy is available

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

- Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse
Effects) Version 4.03 of all clinically significant toxic effects of prior treatment

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Subject has adequate hematologic, hepatic, renal, and coagulation function

- Subject has a life expectancy greater than 3 months

- Subject agrees to use adequate contraception during the study period and for 12 weeks
after last dose of study therapy

- Subject must undergo mandatory biopsies, including one pretreatment and one post
treatment tumor biopsy procedure

Exclusion Criteria:

- Subject has experienced acute pathologic fracture or spinal cord compression within 28
days prior to first dose of study therapy

- Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar
biologic composition as IMC-CS4.

- Subject has received treatment with any monoclonal antibodies within 4 weeks prior to
first dose of study therapy

- Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation
or has experienced a significant injury within 28 days prior to enrollment

- Subject has a concurrent active malignancy other than adequately treated
nonmelanomatous skin cancer or in situ neoplasm

- Subject has an ongoing or active infection, symptomatic congestive heart failure,
uncontrolled hypertension, active bleeding or any other serious uncontrolled medical
disorder

- Subject has known or suspected primary brain or leptomeningeal metastases

- Subject has leukemia or lymphoma

- Subject is know to have active tuberculosis, leishmaniasis, or listeriosis

- Subjects with known history, or clinical or laboratory evidence of liver disease

- Subject has a known active hepatitis B or C infection, Human immunodeficiency virus
(HIV) infection or acquired immunodeficiency syndrome (AIDS)

- Subject if female, is pregnant or breastfeeding

- Subject has received an organ transplant
We found this trial at
6
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: R Kudchadkar
Phone: 404-712-2000
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Cleveland, Ohio 44012
Principal Investigator: UH Cancer Information Services
Phone: 800-641-2422
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Cleveland, OH
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Columbus, Ohio 43210
Principal Investigator: Robert Wesolowski
Phone: 614-293-3873
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Los Angeles, California 90025
Principal Investigator: O Hamid
Phone: 310-582-7900
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New York, NY
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San Francisco, California 94143
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