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Protocol No. UW16137

Principal Investigator Uboha, Nataliya

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title 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 Anti-Pd-1/Pd-L1 Inhibitor Naïve Subjects With Advanced Or Recurrent Solid Tumors Or Lymphomas

Objective The purpose of this research study is to look at the safety and tolerability of CX-072 alone and in combination with ipilimumab or vemurafenib in patients with metastatic or advanced unresectable solid tumors or lymphomas, to determine the highest tolerated dose of CX-072 that can be taken safely, to determine if there is evidence of anti-cancer activity against your specific cancer, to see if there are any side effects due to CX-072 or when taken in combination with ipilimumab or vemurafenib, and to look at how the levels of CX-072 in your blood change over time and how it leaves your body.

Treatment CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are created from antibodies. Antibodies are proteins naturally occurring in the human body to fight infections and in some cases tumors. These antibodies bind to molecules for which they are specific for and cause a reaction of the immune system. The molecule the Probody CX-072 binds to is called PD-L1. PD-L1 tricks your own immune system not to attack the tumor. This can be also called immune escape. Probody X-072 is being developed to see if it can reverse this unwanted immune escape by successfully binding and hence blocking PD-L1. Studies typically evaluate a new substance alone at different doses as well as in combination with other anti-cancer therapies. Depending on what part of the study you are in, you may receive CX-072 on its own, or you may receive CX-072 and Yervoy® (ipilimumab), or you may receive CX-072 and Zelboraf® (vemurafenib).

Description Separate groups of patients will be tested with one of up to seven different doses of CX-072 (study drug). At the various dose levels, CX-072 may be taken alone or in combination with ipilimumab or vemurafenib. CX-072 and ipilimumab are given intravenously (through an IV) and vemurafenib will be taken by mouth. You will be administered CX-072 every two weeks for approximately two years or until your disease worsens. If you are participating in one of the combination treatments, you may be on a 14 day or 21 day schedule during the combination portion. Each participant will be in the study for approximately 2 to 2½ years.

Key Eligibility
  • For Part A: any metastatic or advanced unresectable solid tumor or lymphoma, measurable or non-measurable disease allowed, no further standard of care therapy available that is naïve to treatment with a PD-1/PD-L1 inhibitor or no PD-1/PD-L1 inhibitor therapy is available for their specific disease in the country where they are being treated
  • For Part B1: any metastatic or advanced unresectable solid tumor or lymphoma, measurable or non-measurable disease allowed, no further standard of care therapy available and naïve to treatment with a PD-1/PD-L1 inhibitor, no PD-1/PD-L1 inhibitor therapy available for their specific disease in the country where they are being treated, and naïve to treatment with a CTLA-4 inhibitor
  • For Part B2: any metastatic or advanced unresectable solid tumor or lymphoma with measurable disease allowed, no further standard of care therapy available, previous treatment with a PD-1/PD-L1 inhibitor, discontinued treatment with PD-1/PD-L1 inhibitor for reasons other than toxicity, naïve to treatment with a CTLA-4 inhibitor and agreement to participate in biomarker analysis and have tumor suitable for biopsy(only in cohorts receiving CX-072 + 3 mg ipilimumab [but not 10 mg ipilimumab])
  • For Part C: metastatic or advanced unresectable melanoma with BRAF V600E mutation-positive as detected by a diagnostic approved test, measurable or non-measurable disease allowed, naïve to treatment with BRAF-inhibitor and naïve to treatment with a PD-1/PD-L1 inhibitor
  • For Part D: metastatic or advanced unresectable gastric and GEJ cancers, measurable disease required that is naïve to treatment with a PD-1/PD-L1 inhibitor, subjects that have had their tumor tissue analyzed for PD-L1 may not enroll if they are known to be PD-L1 negative, HER2 negative, for GEJ tumors with significant esophageal component, esophageal cancer Siewert II/III and Subjects must be ineligible for platinum based or fluorpyrimidine basedchemotherapy or approved ramucirumab based regimen or have already received these therapies. Subjects must have had standard of care surgery for their cancer, if applicable
  • Subjects with treated brain metastases are eligible if the brain metastases are stable and the subject does not require radiation therapy, or steroids
  • Patients with prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen are ineligible
  • Patients with Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C are ineligible
  • Patients with a history of or current active autoimmune diseases are ineligible
  • Patients with a history of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications are ineligible
  • Patients with a history of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant are ineligible
  • Women who are pregnant or breastfeeding are ineligible
  • Patients with a known pre-existing condition of age-related macular degeneration are ineligible

Applicable Disease Sites Anal; Bladder; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Head and Neck; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid

Therapies Involved Immunotherapy

Drugs Involved CX-072; RO5185426 (Vemurafenib); Vemurafenib; Yervoy (ipilimumab); ipilimumab

Status Open

Participating Institutions UW Hospital and Clinics