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
Bert O'Neil, MD
Primary Investigator
Overview
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.
Description
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.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
lymphoma,advanced solid tumor
-
Age: Between 18 Years - 100 Years
-
Gender: All
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
Exclusion Criteria
Prior therapy with a chimeric antigen receptor (CAR) T-cell containing 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
