A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

  • Interventional
  • Not Recruiting
  • NCT01375842
Eligibility Details Visit Clinicaltrials.gov

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor

         - Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists

         - Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report

         - Adequate hematologic and end organ function

         - Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma

         - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods

         - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

         - For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)

        Exclusion Criteria:

         - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases

         - Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

         - History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)

         - History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection

         - Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

         - Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1

         - Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation

At a Glance

National Government IDNCT01375842

IRB#IRB14-0712

Lead SponsorGenentech, Inc.

Lead PhysicianRita Nanda

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting