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First in Human Study of AZD9592 in Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05647122.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
New York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
