For Healthcare Professionals

First in Human Study of AZD9592 in Solid Tumors

clipboard-pencil

About the 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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

  1. Age ≥ 18 years
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  3. Life expectancy ≥ 12 weeks
  4. Measurable disease per RECIST v1.1
  5. 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.

EXCLUSION CRITERIA

Key Exclusion Criteria:

  1. 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.
  2. Spinal cord compression or a history of leptomeningeal carcinomatosis.
  3. Active infection including tuberculosis and HBV, HCV or HIV
  4. 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.
  5. Participants with cardiac comorbidities as defined in the study protocol
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study Details


Contition

Advanced Solid Tumours,Carcinoma Non-small Cell Lung,Head and Neck Neoplasms,Colorectal Neoplasms

Age

18+

Phase

PHASE1

Participants Needed

162

Est. Completion Date

Dec 2, 2025

Treatment Type

INTERVENTIONAL


Sponsor

AstraZeneca

ClinicalTrials.gov NCT Identifier

NCT05647122

Study Number

D9350C00001

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.