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. |
ClinicalTrials.gov Identifier: NCT03013491 |
Recruitment Status :
Completed
First Posted : January 6, 2017
Last Update Posted : February 9, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 6, 2021 |
Actual Study Completion Date : | October 6, 2021 |
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 |
- 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) ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
- Agreement to provide mandatory archival tissue or fresh biopsy.
- At least 18 years of age.
Exclusion Criteria:
- Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
- History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
- 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.
- 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.
- History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.
- History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
- Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
- 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.

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
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 | |
Netherlands | |
PROCLAIM Investigative Site | |
Amsterdam, Netherlands, 1007 | |
PROCLAIM Investigative Site | |
Groningen, Netherlands, 9713 GZ | |
PROCLAIM Investigative Site | |
Rotterdam, Netherlands, 3000 CA | |
Poland | |
PROCLAIM Investigative Site | |
Katowice, Poland, 40-960 | |
Spain | |
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 | |
Ukraine | |
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 |
Study Director: | Lawrence Lu, M.D. | CytomX Therapeutics |
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: | February 9, 2022 |
Last Verified: | February 2022 |
cancer checkpoint inhibitor monotherapy combination PD-L1 CTLA-4 |
solid tumor lymphoma BRAF PROCLAIM CX-072 PROCLAIM-CX-072 |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ipilimumab |
Vemurafenib Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |