The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
Research Site
Santa Monica, California, United States
RECRUITINGResearch Site
Providence, Rhode Island, United States
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.
Time frame: Through study completion, up to approximately 2 years
Objective Response Rate (ORR)
The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR). Radiological response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Time frame: Through study completion, up to approximately 2 years
Duration of Response (DoR)
The time from the date of first documented ORR until date of first documented Progression of Disease (PD) or death. Radiological response evaluated according to RECIST v1.1.
Time frame: Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
The percentage of participants who have a best objective response of confirmed CR or PR or who have Stable Disease for at least 11 weeks after start of treatment to allow for an early assessment within the assessment window. Radiological response evaluated according to RECIST v1.1.
Time frame: Through study completion, up to approximately 2 years
Progression Free Survival (PFS)
The time from the start of treatment until the date of objective PD or death. Radiological response evaluated according to RECIST v1.1.
Time frame: Through study completion, up to approximately 2 years
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Research Site
Houston, Texas, United States
RECRUITINGResearch Site
Beijing, China
RECRUITINGResearch Site
Chengdu, China
RECRUITINGResearch Site
Shanghai, China
RECRUITINGResearch Site
Wuhan, China
RECRUITINGResearch Site
Berlin, Germany
NOT_YET_RECRUITINGResearch Site
Dresden, Germany
RECRUITINGResearch Site
Frankfurt, Germany
RECRUITING...and 7 more locations
Overall Survival (OS)
The time from the start of treatment until death due to any cause.
Time frame: Through study completion, up to approximately 2 years
Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration
Plasma concentration of AZD4360, total antibody and other analytes.
Time frame: Through study completion, up to approximately 2 years
Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)
Area under the plasma concentration versus time curve for AZD4360, total antibody and other analytes.
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)
Maximum observed plasma concentration of AZD4360, total antibody and other analytes.
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)
The time it takes for AZD4360, total antibody and other analytes to reach the maximum plasma concentration after administration of the study drug.
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance
A pharmacokinetic measurement of the volume of plasma from which AZD4360, total antibody and other analytes are completely removed per unit time.
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life
The time required for the quantity of AZD4360, total antibody and other analytes to reduce to half of their initial values.
Time frame: Through study completion, up to approximately 2 years