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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of AZD9592
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of AZD9592
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: 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
measured by laboratory and vital sign variables over time including change from baseline
Time frame: From time of Informed Consent to 30 days post last dose of AZD9592
Proportion of patients with radiological response (ORR)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)
Time frame: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
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IV infusion
IV infusion
Research Site
Duarte, California, United States
Research Site
North Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Baltimore, Maryland, United States
Research Site
Milford, Massachusetts, United States
Research Site
Mineola, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
...and 36 more locations
Time frame: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Time frame: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \>=11 weeks from first dose
Time frame: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Time frame: From date of first dose of AZD9592 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause.
Time frame: From date of first dose of AZD9592 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of AZD9592: Plasma PK concentrations
Measurement of plasma concentrations of AZD9592, total antibody and total unconjugated warhead
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Pharmacokinetics of AZD9592: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Pharmacokinetics of AZD9592: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Pharmacokinetics of AZD9592: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Pharmacokinetics of AZD9592: Clearance
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Pharmacokinetics of AZD9592: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Time frame: From date of first dose of AZD9592 up until 30 days post last dose
Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA)
Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment
Time frame: From date of first dose of AZD9592 up until 30 days post last dose