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PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

Trial Status: Active

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

Inclusion Criteria

  • Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  • Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
  • Agreement to provide mandatory archival tissue or fresh biopsy.
  • At least 18 years of age.

Exclusion Criteria

  • Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
  • Serious concurrent illness, including clinically relevant active infection
  • History of or current active autoimmune diseases
  • Significant cardiac disease such as recent myocardial infarction
  • History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
  • Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  • History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  • Currently receiving anticoagulation therapy with warfarin;
  • Major surgery (requiring general anesthesia) within 3 months prior to dosing.

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rose Estrada
Phone: 310-633-8400
USC / Norris Comprehensive Cancer Center
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Suzanne Marie Bailey
Phone: 317-278-4694

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New York

Buffalo
Roswell Park Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Daniel Chang Cho
Phone: 212-731-5445
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: James Joseph Harding
Phone: 646-888-4314
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
CytomX Therapeutics

  • Primary ID CTMX-M-2009-001
  • Secondary IDs NCI-2017-00915
  • Clinicaltrials.gov ID NCT03149549