Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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

Official Title

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)

Keywords

Solid Tumor, AdultBreast CancerNon Small Cell Lung CancerProstate CancerOvarian CancerEndometrial CancerHead and Neck CancerCholangiocarcinomacancersolid tumorPROCLAIMCX-2009PROBODY™ TherapeuticDrug ConjugateAntibody drug conjugateCD166Carcinoma, Non-Small-Cell LungHead and Neck NeoplasmsEndometrial NeoplasmsCX-2009 EscalationCX-2009 Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  1. Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
  2. Serious concurrent illness, including clinically relevant active infection
  3. History of or current active autoimmune diseases
  4. Significant cardiac disease such as recent myocardial infarction
  5. 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;
  6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  8. Currently receiving anticoagulation therapy with warfarin;
  9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.

Locations

  • University of California, Los Angeles (UCLA) - Medical Center accepting new patients
    Santa MonicaCalifornia90404United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los AngelesCalifornia90033United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CytomX Therapeutics
ID
NCT03149549
Phase
Phase 1/2
Study Type
Interventional
Last Updated