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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Neoplasms Advanced Solid Tumors

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Univ of California San Francisco
    San Francisco, California, 94115, United States
  • The Angeles Clinic & Research Institute
    Los Angeles, California, 90025, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT01346358
Phase
Phase 1
Study Type
Interventional
Last Updated
August 4, 2017