A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
Condition: Advanced/Metastatic Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-05082566; KW-0761
Intervention description: Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.; Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
Intervention MeSH terms: Mogamulizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the
      maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D)
      investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with
      advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761
      is estimated (dose finding), one or more expansion cohorts of patients with selected advanced
      solid tumors (dose-expansion ) will be enrolled to further characterize the combination in
      term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and
      biomarkers modulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy.
             Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC,
             bladder, or ovarian carcinomas which have progressed on standard therapy, or for which
             no standard therapy is available.

          -  Measurable disease by RECIST version 1.1.

          -  For Expansion Cohorts only: patients must have tumor accessible for biopsies (core
             needle biopsy or excision preferred).

          -  Age 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate bone marrow, renal and liver function.

          -  Serum/urine pregnancy test (for females of childbearing potential) negative at
             screening and before the patient will receive the study treatment.

          -  Male and female patients of childbearing potential and at risk for pregnancy must
             agree to use two (2) highly effective methods of contraception throughout the study
             and for 60 days after the last dose of assigned study treatment.

        Exclusion Criteria:

          -  Active central nervous system primary or secondary malignancies, active seizure
             disorder, spinal cord compression, or carcinomatous meningitis.

          -  Therapeutic or experimental monoclonal antibodies in last 60 days prior registration.

          -  Systemic anticancer therapy or major surgery within 28 days prior to registration. In
             absence of toxicity from prior systemic anticancer therapy, 5 half-lives since
             completion of prior systemic anticancer therapy is allowed.

          -  Systemic steroids, any other form of immunosuppressive therapy or radiation therapy
             within 14 days prior to registration.

          -  Live vaccine within 30 days prior to registration.

          -  Severe hypersensitivity reaction to treatment with another monoclonal antibody, known
             or suspected hypersensitivity to study drugs or any component of their formulation.

          -  History of autoimmune disease or known inflammatory bowel disease.

          -  Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical
             therapy) or any of the following within 12 months prior to registration: myocardial
             infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle
             branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral
             artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or
             transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac
             dysrhythmias, atrial fibrillation or QTcF interval >470 msec.