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A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

Description

Brief Summary
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


Phase

N/A

Inclusion and Exclusion 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.

  • 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.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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