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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346358
• Other study ID #: 14311
• Secondary ID: CP24-1001I5F-IE-
• Status: Completed
• Phase: Phase 1
• Start date: June 2011
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Biological:
• IMC-CS4

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	Columbia University College of Phys & Surgeons	New York	New York
United States	Univ of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - Maximum concentration (Cmax) of IMC-CS4		Up to Week 36
Primary	Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4		Up to Week 36
Primary	Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4		Up to Week 36
Primary	Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4		Up to Week 36
Primary	Pharmacokinetics -Clearance (Cl) of IMC-CS4		Up to Week 36
Secondary	Recommend Phase 2 Dose (RP2D) of IMC-CS4		Approximately 6 Months
Secondary	Anti-IMC-CS4 Antibody Assessment		Approximately 6 Months