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
- Conditions
- Advanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms
- Registration Number
- JPRN-jRCT2031230002
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 417
Age 18 years or more
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy 12 weeks or more
- 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.
- 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method