Active Not RecruitingPhase 1NCT05647122

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

StatusActive Not Recruiting
PhasePhase 1
U.S. locations46
SponsorAstraZeneca
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

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.

04
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: Jun 11, 2026. Always confirm current availability with the study team.

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