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

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Ovarian Cancer

In brief

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

Key facts

Study ID

NCT03149549

Run by

CytomX Therapeutics

People needed

99

Starts

2017-06-01

Expected to finish

2020-09-10

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• New York University (NYU) Clinical Cancer Center — New York, New York, United States
• Columbia University College of Physicians & Surgeons, Columbia University — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Viriginia Cancer Specialists — Fairfax, Virginia, United States
• Swedish Cancer Institute (SCI) — Seattle, Washington, United States
• University of Wisconsin-Carbone Cancer Center — Madison, Wisconsin, United States
• Amsterdam UMC - Locatie VUmc — Amsterdam, Netherlands
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Instituto Catalan de Oncologia - Hospital Duran i Reynals — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• Centro Integral Oncologico Clara Campal — Madrid, Spain
• Instituto Valenciano de Oncologia — Valencia, Spain
• Beatson, West of Scotland Cancer Centre — Glasgow, United Kingdom
• Sarah Cannon Research Institute UK Limited — London, United Kingdom

Full record on ClinicalTrials.gov

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