JPRN-jRCT2031230002RecruitingPhase 1
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. - EGRET
Hibi Kazushige0 sites417 target enrollmentStarted: April 2, 2023Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 417
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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.
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
Investigators
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