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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
Purpose
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
Professor of Medicine (Oncology)
Susan M. Swetter, MD
Professor of Dermatology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Ash A. Alizadeh, MD/PhD
Moghadam Family Professor
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.
Colleen Haas Chair in the School of Medicine
Eligibility
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
Intervention(s):
drug: Atezolizumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061