Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-10152

Full 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

Purpose

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.

Are you eligible?

Inclusion Criteria:

  • Subject has histologic or cytologic confirmation of advanced solid tumor 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

Exclusion Criteria:

  • Subject has experienced acute pathologic fracture, spinal cord compression, or clinically significant hypercalcemia within 28 days prior to first dose of study therapy
  • Subject has a known hypersensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-CS4.
  • Subject has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
  • Subject has undergone a major surgical procedure, radiation therapy, open biopsy, 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