First in Human Study of AZD9592 in Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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 4 weeks prior to start of study treatment.
- Participants with cardiac comorbidities as defined in the study protocol
Study Locations
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How to Apply
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
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