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 个研究点目标入组 417 人开始时间: 2023年4月2日最近更新: 2024年1月22日

试验速览

暂无简介。

•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

发起方

Hibi Kazushige