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

Status: Closed to Accrual

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.

Eligibility Criteria

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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Temporarily closed to accrual
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Temporarily closed to accrual
Name Not Available
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Contact: Frank Stephen Hodi
Phone: 617-632-5053
Email: stephen_hodi@dfci.harvard.edu

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Genentech Inc.

Trial IDs

Primary ID GO30103
Secondary IDs NCI-2016-01918, 2016-000944-33
Clinicaltrials.gov ID NCT02794571