Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Completed · Phase 1

Conditions studied: Advanced/Metastatic Tumors

In brief

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Key facts

Study ID

NCT02794571

Run by

Genentech, Inc.

People needed

518

Starts

2016-05-23

Expected to finish

2024-11-13

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy at least 12 weeks
• Adequate hematologic and end organ function
• Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
• Confirmed availability of representative tumor specimens
• Measurable disease according to RECIST Version 1.1

You may not qualify if…

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
• Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
• Leptomeningeal disease
• History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
• History of autoimmune disease
• Positive human immunodeficiency virus (HIV) test
• Active hepatitis B or C, or tuberculosis
• Severe infection within 4 weeks prior to randomization
• Prior allogeneic bone marrow or solid organ transplant
• Significant cardiovascular disease
• Known clinically significant liver disease

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• University of California Los Angeles — Santa Monica, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Tennessee Oncology - Nashville — Nashville, Tennessee, United States
• Kinghorn Cancer Centre; St Vincents Hospital — Darlinghurst, New South Wales, Australia
• Peter MacCallum Cancer Center — North Melbourne, Victoria, Australia
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Institut Bergonie CLCC Bordeaux — Bordeaux, France
• Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes — Lyon, France
• Institut Curie — Paris, France
• Institut Claudius Regaud; Departement Oncologie Medicale — Toulouse, France
• Institut Gustave Roussy — Villejuif, France
• National Cancer Center Hospital — Tokyo, Japan
• The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Tokyo, Japan
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• ICO L'Hospitalet; Servicio de oncologia medica — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Univ Vall d'Hebron; Servicio de Oncologia — Sant Andreu de la Barca, Barcelona, Spain
• Clinica Universitaria de Navarra; Servicio de oncología — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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