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First in Human Study of AZD9592 in Solid Tumors
Sponsor: AstraZeneca
Summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
Official title: A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
403
Start Date
2022-12-21
Completion Date
2027-10-06
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
AZD9592
Varying doses of AZD9592
Osimertinib
tablets administered orally
5-Fluorouracil (5-FU)
IV infusion
Leucovorin
IV infusion
Bevacizumab
IV infusion
Locations (50)
Research Site
Duarte, California, United States
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Irvine, California, United States
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North Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Milford, Massachusetts, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Houston, Texas, United States
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Fairfax, Virginia, United States
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Kogarah, Australia
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Melbourne, Australia
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Edmonton, Alberta, Canada
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Toronto, Ontario, Canada
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Beijing, China
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Beijing, China
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Chongqing, China
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Guangzhou, China
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Harbin, China
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Wuhan, China
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Marseille, France
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Rennes, France
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Villejuif, France
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Milan, Italy
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Orbassano, Italy
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Rozzano, Italy
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Verona, Italy
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Chūōku, Japan
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Kashiwa, Japan
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Kōtoku, Japan
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Osaka, Japan
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Taichung, Taiwan
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Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan