GEJ and esophageal cancer, Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-expressing gastric
Conditions
Brief summary
Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, dose-limiting toxicities (DLTs), and changes from baseline in laboratory parameters, vital signs, and electrocardiogram (ECG) results, Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR)
Detailed description
Part 1: Endpoints assessed by Investigator per RECIST v1.1: Confirmed Objective ResponseRate (ORR), Disease control rate (DCR), Duration of response (DoR), Progression-freesurvival (PFS), Overall survival (OS), Part 2, Part 3, Part 4 and Part 5: Endpoints assessed by Investigator per RECISIT v1.1: Diseasecontrol rate (DCR), Duration of response (DoR), Progression-free survival (PFS), Overallsurvival (OS), Part 2, Part 3, Part 4 and Part 5: Occurrence of adverse events (AEs) and serious adverse events(SAEs), dose-limiting toxicities (DLTs) and changes from baseline in laboratory parameters, vital signs, body weight and electrocardiogram (ECG) results, Part 2, Part 3, Part 4 and Part 5: -Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms; -Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab; -Serum concentrations of volrustomig and rilvegostomig in study arms including T-DXd incombination with volrustomig and T-DXd in combination with rilvegostomig,, -Presence of ADAs for T-DXd, durvalumab, volrustomig and rilvegostomig (in study arms including T-DXd and durvalumab T-DXd and volrustomig, and T-DXd and rilvegostomig, respectively) -Comparison of ORR, DCR, DoR, PFS, OS between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results
Interventions
DRUGOXALIPLATIN
DRUGCAPECITABINE
DRUGTRASTUZUMAB
DRUGRilvegostomig
DRUGCISPLATIN
DRUGvolrustomig
DRUGDS-8201a
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGPEMBROLIZUMAB
DRUGFLUOROURACIL
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, dose-limiting toxicities (DLTs), and changes from baseline in laboratory parameters, vital signs, and electrocardiogram (ECG) results, Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Endpoints assessed by Investigator per RECIST v1.1: Confirmed Objective ResponseRate (ORR), Disease control rate (DCR), Duration of response (DoR), Progression-freesurvival (PFS), Overall survival (OS), Part 2, Part 3, Part 4 and Part 5: Endpoints assessed by Investigator per RECISIT v1.1: Diseasecontrol rate (DCR), Duration of response (DoR), Progression-free survival (PFS), Overallsurvival (OS), Part 2, Part 3, Part 4 and Part 5: Occurrence of adverse events (AEs) and serious adverse events(SAEs), dose-limiting toxicities (DLTs) and changes from baseline in laboratory parameters, vital signs, body weight and electrocardiogram (ECG) results, Part 2, Part 3, Part 4 and Part 5: -Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms; -Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab; -Serum concentrations of volrustomig and rilvegostomig in study arms including T-DXd incombination with volrustomig and T-DX | — |
Countries
Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed