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:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:May 23, 2016
End Date:June 2, 2020
Contact:Reference Study ID Number: GO30103 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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

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.


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
We found this trial at
11
sites
370 Victoria Street
Darlinghurst, New South Wales 2010
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Aurora, Colorado 80045
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Nashville, Tennessee 37203
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Nashville, TN
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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405 Hilgard Avenue
Santa Monica, California 90404
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Santa Monica, CA
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10510 North 92nd Street
Scottsdale, Arkansas 85258
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Scottsdale, AR
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