A Study of IMC-CS4 in Subjects With Advanced Solid Tumors
NCT ID: NCT01346358
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2011-06-15
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IMC-CS4 Weight Based Dosing
Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A.
IMC-CS4
IMC-CS4 Non-Weight Based Dosing
Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B.
IMC-CS4
Interventions
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IMC-CS4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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The Angeles Clinic & Research Institute
Los Angeles, California, United States
Univ of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Columbia University College of Phys & Surgeons
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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Dowlati A, Harvey RD, Carvajal RD, Hamid O, Klempner SJ, Kauh JSW, Peterson DA, Yu D, Chapman SC, Szpurka AM, Carlsen M, Quinlan T, Wesolowski R. LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. Invest New Drugs. 2021 Aug;39(4):1057-1071. doi: 10.1007/s10637-021-01084-8. Epub 2021 Feb 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP24-1001
Identifier Type: OTHER
Identifier Source: secondary_id
I5F-IE-JSCA
Identifier Type: OTHER
Identifier Source: secondary_id
14311
Identifier Type: -
Identifier Source: org_study_id
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