Biliary Tract Cancer, Gastric Cancer, Gastroesophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
Frequency of DLTs (dose escalation cohort), Incidence of AEs, SAEs, and AEs leading to discontinuation of AZD4360, Assess clinically significant changes in vital signs, laboratory parameters, and ECG results
Detailed description
Radiological response evaluated according to RECISTv1.1: Overall Response Rate, Duration of Response,Disease Control Rate, and Progression-free Survival, Overall Survival, Pharmamokinetics end points: Plasma concentration of AZD4360 total antibody and other analytes, Plasma PK parameters of AZD4360, total antibody andother analytes including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, Immunogenecitiy end point: Number and percentage of participants who develop ADA against AZD4360
Interventions
DRUGAZD4360
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of DLTs (dose escalation cohort), Incidence of AEs, SAEs, and AEs leading to discontinuation of AZD4360, Assess clinically significant changes in vital signs, laboratory parameters, and ECG results | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological response evaluated according to RECISTv1.1: Overall Response Rate, Duration of Response,Disease Control Rate, and Progression-free Survival, Overall Survival, Pharmamokinetics end points: Plasma concentration of AZD4360 total antibody and other analytes, Plasma PK parameters of AZD4360, total antibody andother analytes including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow, Immunogenecitiy end point: Number and percentage of participants who develop ADA against AZD4360 | — |
Countries
Germany
Outcome results
None listed