PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Solid Tumor, Unresectable or Metastatic Melanoma
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Combination, ipilimumab, Cancer, checkpoint inhibitor, PD-L1, CTLA-4, PROCLAIM, PROCLAIM-CX-072, Relapsed, Refractory
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Measurable disease as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Agree to provide tumor tissue and blood samples for biomarker assessment
Exclusion Criteria:
- Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
- Prior therapy with a chimeric antigen receptor T cell-containing regimen
- 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
- History of myocarditis regardless of the cause
- History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
- History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
- History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
Sites / Locations
- City of Hope National Medical Center
- The Angeles Clinic and Research Institute
- Beacon Cancer Care
- University of Chicago
- Norton Cancer Institute
- Dana Farber Cancer Institute
- NYC Cancer Institute
- Columbia Medical Center
- Oregon Health & Science Center
- Providence Portland Medical Center
- UPMC Hillman Cancer Center
- Inova Dwight and March Schar Cancer Institute
- Virginia Cancer Specialists
- Multicare Institute for Research and Innovation
- Sunshine Coast University Private Hospital
- Ballarat Oncology and Haematology Services
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital Yonsei University Health System
- The Netherlands Cancer Institute
- University Medical Center Groningen
- ICO Hospitalet, Hospital Duran I Reynals
- Hospital Clinic de Barcelona. Servicio Oncologia Medica
- Hospital Universitario La Paz
- START- Madrid
- Clinica Universitaria de Navarra
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
CX-072 in combination with anti-cancer therapy-front line
CX-072 in combination with ipilimumab
CX-072 in combination with anti-cancer therapy-Progressed
CX-072 in combination with anti-cancer therapy-Neoadjuvant
histologically or cytologically confirmed solid tumor who have received no prior treatment
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
histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
neo-adjuvant study in subjects with histologically confirmed solid tumor