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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013491
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Drug: CX-072 Drug: ipilimumab Drug: vemurafenib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CX-072
Monotherapy CX-072
Drug: CX-072
Experimental: CX-072 with Ipilimumab #1
Combination CX-072 + ipilimumab (Schedule 1)
Drug: CX-072
Drug: ipilimumab
Experimental: CX-072 with Ipilimumab #2
Combination CX-072 + ipilimumab (Schedule 2)
Drug: CX-072
Drug: ipilimumab
Experimental: CX-072 with Vemurafenib
Combination CX-072 + vemurafenib
Drug: CX-072
Drug: vemurafenib
Experimental: CX-072 expansion
Monotherapy CX-072
Drug: CX-072



Primary Outcome Measures :
  1. The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib [ Time Frame: 28 days (dose limiting toxicity period) ]

Secondary Outcome Measures :
  1. The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib [ Time Frame: 2 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013491


Contacts
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Contact: Vanessa Huels clinicaltrials@cytomx.com

Locations
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United States, Arizona
PROCLAIM Investigative Site Withdrawn
Scottsdale, Arizona, United States, 85258
United States, California
PROCLAIM Investigative Site Recruiting
Los Angeles, California, United States, 90025
PROCLAIM Investigative Site Recruiting
Los Angeles, California, United States, 90033
United States, Connecticut
PROCLAIM Investigative Site Recruiting
New Haven, Connecticut, United States, 06520
United States, Illinois
PROCLAIM Investigative Site Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
PROCLAIM Investigative Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
PROCLAIM Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
PROCLAIM Investigative Site Recruiting
Detroit, Michigan, United States, 48201
United States, New York
PROCLAIM Investigative Site Withdrawn
Buffalo, New York, United States, 14263
PROCLAIM Investigative Site Recruiting
New York, New York, United States, 10016
PROCLAIM Investigative Site Recruiting
New York, New York, United States, 10032
PROCLAIM Investigative Site Recruiting
New York, New York, United States, 10065
United States, Ohio
PROCLAIM Investigative Site Withdrawn
Cleveland, Ohio, United States, 44106
United States, Oregon
PROCLAIM Investigative Site Recruiting
Portland, Oregon, United States, 97213
United States, Tennessee
PROCLAIM Investigative Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
PROCLAIM Investigative Site Recruiting
Dallas, Texas, United States, 75230
PROCLAIM Investigative Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
PROCLAIM Investigative Site Withdrawn
Salt Lake City, Utah, United States, 84112
United States, Virginia
PROCLAIM Investigative Site Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
PROCLAIM Investigative Site Withdrawn
Seattle, Washington, United States, 98104
United States, Wisconsin
PROCLAIM Investigative Site Recruiting
Madison, Wisconsin, United States, 53579
Hungary
PROCLAIM Investigative Site Withdrawn
Debrecen, Hungary
Netherlands
PROCLAIM Investigative Site Recruiting
Amsterdam, Netherlands, 1007
PROCLAIM Investigative Site Recruiting
Groningen, Netherlands, 9713 GZ
PROCLAIM Investigative Site Recruiting
Rotterdam, Netherlands, 3000 CA
PROCLAIM Investigative Site Recruiting
Rotterdam, Netherlands, 3000
Poland
PROCLAIM Investigative Site Withdrawn
Katowice, Poland, 40-960
PROCLAIM Investigative Site Withdrawn
Kraków, Poland, 31-826
PROCLAIM Investigative Site Withdrawn
Warszawa, Poland, 02-781
Spain
PROCLAIM Investigative Site Recruiting
Pamplona, Navarre, Spain, 31008
PROCLAIM Investigative Site Recruiting
Barcelona, Spain, 08908
PROCLAIM Investigative Site Recruiting
Barcelona, Spain, 8036
PROCLAIM Investigative Site Recruiting
Madrid, Spain, 28046
PROCLAIM Investigative Site Recruiting
Madrid, Spain, 28050
PROCLAIM Investigative Ssite Recruiting
Valencia, Spain, 46009
Ukraine
PROCLAIM Investigative Site Recruiting
Dnepropetrovsk, Ukraine, 49102
PROCLAIM Investigative Site Withdrawn
Kyiv, Ukraine, 3115
PROCLAIM Investigative Site Withdrawn
Zaporozhye, Ukraine, 69104
United Kingdom
PROCLAIM Invetigative Site Recruiting
Glasgow, United Kingdom, G12 0YN
PROCLAIM Investigative Site Recruiting
London, United Kingdom, W1G 6AD
PROCLAIM Investigative Site Recruiting
Manchester, United Kingdom, M20 4BX
PROCLAIM Investigative Site Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
PROCLAIM Investigative Site Withdrawn
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Glenn Michelson, M.D. CytomX Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03013491    
Other Study ID Numbers: CTMX-M-072-001
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: November 2019
Keywords provided by CytomX Therapeutics:
cancer
checkpoint inhibitor
monotherapy
combination
PD-L1
CTLA-4
solid tumor
lymphoma
BRAF
PROCLAIM
CX-072
PROCLAIM-CX-072
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ipilimumab
Vemurafenib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action