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.
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Incidence of Adverse Events (AEs)
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
Incidence of Serious Adverse Events (SAEs)
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Timeframe: From time of first dose of AZD9592 to end of DLT period (approximately 21 days)
Incidence of baseline laboratory finding, ECG and vital signs changes
Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592
Proportion of patients with radiological response (ORR)
Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
AstraZeneca Clinical Study Information Center