PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas



Status:Recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:January 2017
End Date:December 2021
Contact:Vanessa Huels
Email:clinicaltrials@cytomx.com

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An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas

The purpose of this first-in-human study of CX-072 is to characterize the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072
administered intravenously (IV) as a single agent or in combination with ipilimumab or
vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.
PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial

CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).
Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the
therapeutic index by minimizing drug interaction with normal tissue while retaining
anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in
healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific
protease activity.

PROBODY is a trademark of CytomX Therapeutics, Inc.


Inclusion Criteria:

1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that
progressed on standard therapy

2. Agreement to provide mandatory archival tissue or fresh biopsy.

3. At least 18 years of age.

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.

2. History of severe allergic or anaphylactic reactions to human monoclonal antibody
therapy or known hypersensitivity to any Probody therapeutic.

3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus
(HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis
B or C.

4. History of or current active autoimmune diseases, including but not limited to
inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune
hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis,
autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.

5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg
daily prednisone equivalents) or immunosuppressive medications.

6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow
transplant.

7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational
treatment within 30 days prior to receiving any study drug.

8. Major surgery (requiring general anesthesia) within 3 months or minor surgery
(excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment
within 14 days (with adequate healing) of administration of any study drug.
We found this trial at
19
sites
Seattle, Washington
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Boston, Massachusetts
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Boston, MA
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Buffalo, New York
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Buffalo, NY
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330 North Wabash Avenue
Chicago, Illinois 60612
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Chicago, IL
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Cleveland, Ohio
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Cleveland, OH
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Dallas, TX
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Debrecen,
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Detroit, Michigan 48201
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Detroit, MI
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Fairfax, Virginia
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Fairfax, VA
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Houston, TX
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Indianapolis, Indiana
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Indianapolis, IN
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Los Angeles, California 90025
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Madison, Wisconsin
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Madison, WI
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Nashville, Tennessee
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Nashville, TN
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New Haven, Connecticut 06520
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New Haven, CT
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New York, New York
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New York, NY
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Portland, Oregon
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Portland, OR
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Salt Lake City, Utah 84112
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Salt Lake City, UT
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Scottsdale, Arizona
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Scottsdale, AZ
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