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



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Ovarian Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/29/2018
Start Date:June 1, 2017
End Date:December 2021
Contact:Lori Carman
Email:clinicaltrials@cytomx.com
Phone:650-515-3185

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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)

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:

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.

Exclusion Criteria:

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.
We found this trial at
22
sites
Salt Lake City, Utah 84112
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Amsterdam,
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Cleveland, OH
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Dallas, TX
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8503 Arlington Boulevard
Fairfax, Virginia 22031
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Fairfax, VA
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Houston, Texas 77030
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Houston, TX
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Indianapolis, IN
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, CA
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Madison, WI
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Santa Monica, CA
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1221 Madison Street
Seattle, Washington 98104
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Seattle, WA
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