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 |
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.
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
Columbus, Ohio 43210
Principal Investigator: Robert Wesolowski
Phone: 614-293-3873
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201 Dowman Dr
Atlanta, Georgia 30303
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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Los Angeles, California 90025
Principal Investigator: O Hamid
Phone: 310-582-7900
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