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

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ClinicalTrials.gov Identifier: NCT01346358
Recruitment Status : Completed
First Posted : May 3, 2011
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Biological: IMC-CS4 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2011
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: IMC-CS4 Weight Based Dosing
Participants receiving IMC-CS4 intravenously (weight based dosing)
 Biological: IMC-CS4
Other Name: LY3022855
Experimental: IMC-CS4 Non-Weight Based Dosing
Participants receiving IMC-CS4 intravenously (non-weight based dosing)
 Biological: IMC-CS4
Other Name: LY3022855


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics - Maximum concentration (Cmax) of IMC-CS4 [ Time Frame: Up to Week 36 ]
  2. Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4 [ Time Frame: Up to Week 36 ]
  3. Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4 [ Time Frame: Up to Week 36 ]
  4. Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4 [ Time Frame: Up to Week 36 ]
  5. Pharmacokinetics -Clearance (Cl) of IMC-CS4 [ Time Frame: Up to Week 36 ]

Secondary Outcome Measures :
  1. Recommend Phase 2 Dose (RP2D) of IMC-CS4 [ Time Frame: Approximately 6 Months ]
  2. Anti-IMC-CS4 Antibody Assessment [ Time Frame: Approximately 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346358


Locations
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United States, California
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
Univ of California San Francisco
San Francisco, California, United States, 94115
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, New York
Columbia University College of Phys & Surgeons
New York, New York, United States, 10032
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-5055
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01346358    
Other Study ID Numbers: 14311
CP24-1001 ( Other Identifier: ImClone Systems )
I5F-IE-JSCA ( Other Identifier: Eli Lilly and Company )
First Posted: May 3, 2011    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors