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

Not Recruiting

Trial ID: NCT01375842


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.

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD

Moghadam Family Professor

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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


drug: Atezolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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