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Phase I

A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MTIG7192A as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors

  • Study HIC#:1604017588
  • Last Updated:03/07/2021

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.

  • Age18 years and older
  • GenderBoth
  • Start Date06/28/2016
  • End Date10/31/2022

Trial Purpose and Description

Primary Outcome Measures:

  • Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: From Baseline to the end of Cycle 1 (up to 21 days) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 [ Time Frame: From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 3 years) ] [ Designated as safety issue: No ]
  • Number of Cycles with MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ] [ Designated as safety issue: No ]
  • Dosage in Milligrams (mg) of MTIG7192A [ Time Frame: From Baseline to last dose (up to approximately 3 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to MTIG7192A [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 hours [h]) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then every eight cycles (Q8C) until/at discontinuation (DC) (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with ATAs to Atezolizumab [ Time Frame: From Baseline to last ATA measurement; drawn pre-dose (0 h) Day 1 of Cycles 1-4, 8 (cycle = 21 days); then Q8C until/at DC (up to 3 years); every 30 days thereafter up to 120 days (up to 3 years overall) ] [ Designated as safety issue: Yes ]

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

Sub-Investigators

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