PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas
NCT ID: NCT03013491
Last Updated: 2025-06-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
196 participants
INTERVENTIONAL
2017-01-19
2020-10-27
Brief Summary
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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 U.S. registered trademark of CytomX Therapeutics, Inc.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CX-072 #1
Monotherapy CX-072 (Part A)
CX-072
Solution for infusion
CX-072 #2
Monotherapy CX-072 (Part A2)
CX-072
Solution for infusion
CX-072 with Ipilimumab #1
Combination CX-072 + ipilimumab (Part B1)
CX-072
Solution for infusion
ipilimumab
Solution for infusion
CX-072 with Ipilimumab #2
Combination CX-072 + ipilimumab (Part B2)
CX-072
Solution for infusion
ipilimumab
Solution for infusion
CX-072 with Vemurafenib
Combination CX-072 + vemurafenib (Part C)
CX-072
Solution for infusion
vemurafenib
Tablet
CX-072 expansion
Monotherapy CX-072 (Part D)
CX-072
Solution for infusion
CX-072 long-term extension
Monotherapy CX-072
CX-072
Solution for infusion
Interventions
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CX-072
Solution for infusion
ipilimumab
Solution for infusion
vemurafenib
Tablet
Eligibility Criteria
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Inclusion Criteria
2. Agreement to provide mandatory archival tissue or fresh biopsy.
3. At least 18 years of age.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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CytomX Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Monika Vainorius, M.D.
Role: STUDY_DIRECTOR
CytomX Therapeutics
Locations
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PROCLAIM Investigative Site
Los Angeles, California, United States
PROCLAIM Investigative Site
Los Angeles, California, United States
PROCLAIM Investigative Site
New Haven, Connecticut, United States
PROCLAIM Investigative Site
Chicago, Illinois, United States
PROCLAIM Investigative Site
Indianapolis, Indiana, United States
PROCLAIM Investigative Site
Boston, Massachusetts, United States
PROCLAIM Investigative Site
Detroit, Michigan, United States
PROCLAIM Investigative Site
New York, New York, United States
PROCLAIM Investigative Site
New York, New York, United States
PROCLAIM Investigative Site
New York, New York, United States
PROCLAIM Investigative Site
Portland, Oregon, United States
PROCLAIM Investigative Site
Nashville, Tennessee, United States
PROCLAIM Investigative Site
Dallas, Texas, United States
PROCLAIM Investigative Site
Houston, Texas, United States
PROCLAIM Investigative Site
Fairfax, Virginia, United States
PROCLAIM Investigative Site
Madison, Wisconsin, United States
PROCLAIM Investigative Site
Amsterdam, , Netherlands
PROCLAIM Investigative Site
Groningen, , Netherlands
PROCLAIM Investigative Site
Rotterdam, , Netherlands
PROCLAIM Investigative Site
Katowice, , Poland
PROCLAIM Investigative Site
Pamplona, Navarre, Spain
PROCLAIM Investigative Site
Barcelona, , Spain
PROCLAIM Investigative Site
Barcelona, , Spain
PROCLAIM Investigative Site
Madrid, , Spain
PROCLAIM Investigative Site
Madrid, , Spain
PROCLAIM Investigative Ssite
Valencia, , Spain
PROCLAIM Investigative Site
Dnipro, , Ukraine
PROCLAIM Invetigative Site
Glasgow, , United Kingdom
PROCLAIM Investigative Site
London, , United Kingdom
PROCLAIM Investigative Site
Manchester, , United Kingdom
PROCLAIM Investigative Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Naing A, Thistlethwaite F, De Vries EGE, Eskens FALM, Uboha N, Ott PA, LoRusso P, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Randhawa M, Durm G, Gil-Martin M, Stroh M, Hannah AL, Arkenau HT, Spira A. CX-072 (pacmilimab), a Probody (R) PD-L1 inhibitor, in advanced or recurrent solid tumors (PROCLAIM-CX-072): an open-label dose-finding and first-in-human study. J Immunother Cancer. 2021 Jul;9(7):e002447. doi: 10.1136/jitc-2021-002447.
Sanborn RE, Hamid O, de Vries EG, Ott PA, Garcia-Corbacho J, Boni V, Bendell J, Autio KA, Cho DC, Plummer R, Stroh M, Lu L, Thistlethwaite F. CX-072 (pacmilimab), a Probody PD-L1 inhibitor, in combination with ipilimumab in patients with advanced solid tumors (PROCLAIM-CX-072): a first-in-human, dose-finding study. J Immunother Cancer. 2021 Jul;9(7):e002446. doi: 10.1136/jitc-2021-002446.
Giesen D, Broer LN, Lub-de Hooge MN, Popova I, Howng B, Nguyen M, Vasiljeva O, de Vries EGE, Pool M. Probody Therapeutic Design of 89Zr-CX-072 Promotes Accumulation in PD-L1-Expressing Tumors Compared to Normal Murine Lymphoid Tissue. Clin Cancer Res. 2020 Aug 1;26(15):3999-4009. doi: 10.1158/1078-0432.CCR-19-3137. Epub 2020 Jan 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTMX-M-072-001
Identifier Type: -
Identifier Source: org_study_id
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