PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
NCT ID: NCT03993379
Last Updated: 2025-12-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2019-11-20
2020-05-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CX-072 in combination with anti-cancer therapy-front line
histologically or cytologically confirmed solid tumor who have received no prior treatment
CX-072
CX-072 in combination with ipilimumab
CX-072 in combination with ipilimumab
histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
CX-072
CX-072 in combination with ipilimumab
Ipilimumab
CX-072 in combination with ipilimumab
CX-072 in combination with anti-cancer therapy-Progressed
histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
CX-072
CX-072 in combination with ipilimumab
CX-072 in combination with anti-cancer therapy-Neoadjuvant
neo-adjuvant study in subjects with histologically confirmed solid tumor
CX-072
CX-072 in combination with ipilimumab
Interventions
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CX-072
CX-072 in combination with ipilimumab
Ipilimumab
CX-072 in combination with ipilimumab
Eligibility Criteria
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Inclusion Criteria
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment
Exclusion Criteria
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
18 Years
ALL
No
Sponsors
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CytomX Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Lu, MD
Role: STUDY_DIRECTOR
CytomX Therapeutics
Locations
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City of Hope National Medical Center
Duarte, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Beacon Cancer Care
Coeur d'Alene, Idaho, United States
University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
NYC Cancer Institute
New York, New York, United States
Columbia Medical Center
New York, New York, United States
Oregon Health & Science Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Inova Dwight and March Schar Cancer Institute
Fairfax, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Multicare Institute for Research and Innovation
Spokane, Washington, United States
Sunshine Coast University Private Hospital
Sunshine Coast, Queensland, Australia
Ballarat Oncology and Haematology Services
Wendouree, Victoria, Australia
The Netherlands Cancer Institute
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
ICO Hospitalet, Hospital Duran I Reynals
Barcelona, , Spain
Hospital Clinic de Barcelona. Servicio Oncologia Medica
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
START- Madrid
Madrid, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CTMX-M-072-002
Identifier Type: -
Identifier Source: org_study_id