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.

Who can take part?

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

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:
6. Histologically or cytologically confirmed metastatic or locally advanced EGFRmut. NSCLC; metastatic EGFRwt. NSCLC; recurrant or metastatic HNSCC of the oral cavity Additional Inclusion Criteria for Module 2
7. Histologically or cytologically confirmed metastatic NSCLC EGFRmut. 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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.