Advanced solid tumors, HER2 mutation
Conditions
Brief summary
Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)
Detailed description
Duration of response (DOR) per RECIST 1.1 as assessed by BICR, Time to response (TTR) per RECIST 1.1 as assessed by BICR, ORR per RECIST 1.1 as assessed by the investigator, Disease control rate (DCR) per RECIST 1.1 as assessed by BICR, DCR ≥12 weeks per RECIST 1.1 as assessed by BICR, Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR, Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator, DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator, Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator, DOR per RECIST 1.1 as assessed by the investigator, TTR per RECIST 1.1 as assessed by the investigator, Overall survival (OS), Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity. Number of participants who discontinue study treatment due to an AE, Time to deterioration in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 physical functioning domain score, Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) per RECIST 1.1 as assessed by BICR, Time to response (TTR) per RECIST 1.1 as assessed by BICR, ORR per RECIST 1.1 as assessed by the investigator, Disease control rate (DCR) per RECIST 1.1 as assessed by BICR, DCR ≥12 weeks per RECIST 1.1 as assessed by BICR, Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR, Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator, DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator, Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator, DOR per RECIST 1.1 as assessed by the investigator, TTR per RECIST 1.1 as assessed by the investigator, Overall survival (OS), Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity. Number of participants who discontinue study treatment due to an AE, Time to deterioration in EORTC QLQ-C30 physical functioning domai | — |
Countries
Denmark, France, Italy, Spain