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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. Read our disclaimer for details. Identifier: NCT03013491
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : August 5, 2021
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
Actual Primary Completion Date : October 27, 2020
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03013491

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United States, California
PROCLAIM Investigative Site
Los Angeles, California, United States, 90025
PROCLAIM Investigative Site
Los Angeles, California, United States, 90033
United States, Connecticut
PROCLAIM Investigative Site
New Haven, Connecticut, United States, 06520
United States, Illinois
PROCLAIM Investigative Site
Chicago, Illinois, United States, 60612
United States, Indiana
PROCLAIM Investigative Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
PROCLAIM Investigative Site
Boston, Massachusetts, United States, 02215
United States, Michigan
PROCLAIM Investigative Site
Detroit, Michigan, United States, 48201
United States, New York
PROCLAIM Investigative Site
New York, New York, United States, 10016
PROCLAIM Investigative Site
New York, New York, United States, 10032
PROCLAIM Investigative Site
New York, New York, United States, 10065
United States, Oregon
PROCLAIM Investigative Site
Portland, Oregon, United States, 97213
United States, Tennessee
PROCLAIM Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
PROCLAIM Investigative Site
Dallas, Texas, United States, 75230
PROCLAIM Investigative Site
Houston, Texas, United States, 77030
United States, Virginia
PROCLAIM Investigative Site
Fairfax, Virginia, United States, 22031
United States, Wisconsin
PROCLAIM Investigative Site
Madison, Wisconsin, United States, 53579
PROCLAIM Investigative Site
Amsterdam, Netherlands, 1007
PROCLAIM Investigative Site
Groningen, Netherlands, 9713 GZ
PROCLAIM Investigative Site
Rotterdam, Netherlands, 3000 CA
PROCLAIM Investigative Site
Katowice, Poland, 40-960
PROCLAIM Investigative Site
Pamplona, Navarre, Spain, 31008
PROCLAIM Investigative Site
Barcelona, Spain, 08908
PROCLAIM Investigative Site
Barcelona, Spain, 8036
PROCLAIM Investigative Site
Madrid, Spain, 28046
PROCLAIM Investigative Site
Madrid, Spain, 28050
PROCLAIM Investigative Ssite
Valencia, Spain, 46009
PROCLAIM Investigative Site
Dnepropetrovsk, Ukraine, 49102
United Kingdom
PROCLAIM Invetigative Site
Glasgow, United Kingdom, G12 0YN
PROCLAIM Investigative Site
London, United Kingdom, W1G 6AD
PROCLAIM Investigative Site
Manchester, United Kingdom, M20 4BX
PROCLAIM Investigative Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
CytomX Therapeutics
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Study Director: Lawrence Lu, M.D. CytomX Therapeutics
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CytomX Therapeutics Identifier: NCT03013491    
Other Study ID Numbers: CTMX-M-072-001
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Keywords provided by CytomX Therapeutics:
checkpoint inhibitor
solid tumor
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors