First in Human Study of AZD9592 in Solid Tumors
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.
Checked against the public recordLast updated Jun 11, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: AZD9592; Drug: Osimertinib; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin; Drug: Bevacizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 2 weeks prior to start of study treatment. * Participants with cardiac comorbidities as defined in the study protocol
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteDuarte, California
- Research SiteNorth Haven, Connecticut
- Research SiteWashington D.C., District of Columbia
- Research SiteChicago, Illinois
- Research SiteBaltimore, Maryland
- Research SiteBaltimore, Maryland
- Research SiteMilford, Massachusetts
- Research SiteMineola, New York
- Research SiteNew York, New York
- Research SiteNew York, New York
- Research SiteNew York, New York
- Research SitePhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 11, 2026. Always confirm current availability with the study team.