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First in Human Study of AZD9592 in Solid Tumors
NCT05647122 · AstraZeneca
In plain English
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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
About this study
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.
Eligibility criteria
Key Inclusion Criteria:
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key Exclusion Criteria:
* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Spinal cord compression or a history of leptomeningeal carcinomatosis.
* Active infection including tuberculosis and HBV, HCV or HIV
* Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment.
* Participants with cardiac comorbidities as defined in the study protocol
Study design
Enrollment target: 403 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-12-21
Estimated completion: 2027-10-06
Last updated: 2026-02-20
Interventions
Drug: AZD9592Drug: OsimertinibDrug: 5-Fluorouracil (5-FU)Drug: LeucovorinDrug: Bevacizumab
Primary outcomes
- • Incidence of Adverse Events (AEs) (From time of Informed Consent to 30 days post last dose of AZD9592)
- • Incidence of Serious Adverse Events (SAEs) (From time of Informed Consent to 30 days post last dose of AZD9592)
- • Incidence of dose-limiting toxicities (DLT) as defined in the protocol (From time of first dose of AZD9592 to end of DLT period (approximately 21 days))
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorCharu Aggarwal, MD, MPH · principal_investigator, University of Pennsylvania
All locations (50)
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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
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Taipei, Taiwan
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Taoyuan District, Taiwan