A Phase I, Multicenter, Open-label, First-in Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors
Trial Description
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.
Eligibility Requirements
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 4 weeks prior to start of study
treatment.
- Participants with cardiac comorbidities as defined in the study protocol