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

  • STATUS
    Recruiting
  • End date
    Oct 5, 2024
  • participants needed
    660
  • sponsor
    Genentech, Inc.
Updated on 22 October 2022

Summary

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.

Details
Condition Advanced/Metastatic Tumors
Treatment Capecitabine, cisplatin, etoposide, carboplatin, Paclitaxel, bevacizumab, Pembrolizumab, Pemetrexed, Atezolizumab, MTIG7192A, Tiragolumab
Clinical Study IdentifierNCT02794571
SponsorGenentech, Inc.
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
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