Safety and Pharmacokinetics (PK) of Escalating Doses of MTIG7192A as a Single Agent and in Combination With Atezolizumab in Locally Advanced or Metastatic Tumors

Description

This first-in-human open-label, multicenter, dose-escalation study is designed to evaluate the safety, tolerability, and PK of MTIG7192A alone or in combination with atezolizumab 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.

Study Start Date

May, 23 2016

Estimated Completion Date

September 2019

Interventions

  • Drug: Atezolizumab
  • Drug: MTIG7192A

Study ID

Genentech, Inc. -- GO30103

Status

Recruiting

Trial ID

NCT02794571

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

300

Sponsor

Genentech, Inc.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (31)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 357.9 miles None None None
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 357.9 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Tennessee Onc PLLC SCRI - Nashville, Tennessee 942.8 miles None None None
Honor Health Research Institute - Scottsdale, Arkansas 2,286.1 miles None None None
University of California Los Angeles - Santa Monica, California 2,607.9 miles None None None

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