First in Human Study of AZD9592 in Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAZD9592 and Osimertinib

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?46 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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.

Study sites

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: Sep 25, 2026. Always confirm current availability with the study team.

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