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

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-001: PRObody CLinical Assessment In Man CX-072 clinical trial 001.

Cancer (Oncology), Cancer (Oncology) - All Solid Tumors, Cancer (Oncology) - Cholangiocarcinoma, Cancer (Oncology) - Bladder, Cancer (Oncology) - Breast, Cancer (Oncology) - Colon, Cancer (Oncology) - Colorectal, Cancer (Oncology) - Endometrial, Cancer (Oncology) - Esophageal, Cancer (Oncology) - Gastroesophageal Junction, Cancer (Oncology) - Gynecology, Cancer (Oncology) - Kidney, Cancer (Oncology) - Liver, Cancer (Oncology) - Lung, Cancer (Oncology) - Lymphoma, Cancer (Oncology) - Pancreas, Cancer (Oncology) - Peritoneal, Cancer (Oncology) - Prostate, Cancer (Oncology) - Rectal, Cancer (Oncology) - Renal, Cancer (Oncology) - Stomach, Cancer (Oncology) - Head and Neck, Cancer (Oncology) - Melanoma
Erin Ellis, MD

Swedish Cancer Institute

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
  2. Agreement to provide mandatory archival tissue or fresh biopsy.
  3. At least 18 years of age.

Exclusion Criteria:

  1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
  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.
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