Metastatic uveal melanoma, other GNAQ/11 mutant melanomas (e.g. skin or mucosal melanoma)
Conditions
Brief summary
Phase I: Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment., Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs., Phase I: Frequency of dose interruptions, reductions, and discontinuations., Phase II: Overall Response rate (ORR) per RECIST 1.1.
Detailed description
Phase I and Phase II: PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)., Phase I: Prevalence and incidence of anti-DYP688 antibodies., Phase I: Best Overall Response (BOR)., Phase I: Overall Response Rate (ORR) per RECIST v1.1., Phase II: Duration of response (DoR), progression free survival (PFS) and DCR per RECIST v1.1., Phase II: Overall survival (OS), Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs., Phase II: Frequency of dose interruptions, reductions, and discontinuations PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)., Phase II: Prevalence and incidence of anti-DYP688 antibodies.
Interventions
DRUGDYP688
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment., Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs., Phase I: Frequency of dose interruptions, reductions, and discontinuations., Phase II: Overall Response rate (ORR) per RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I and Phase II: PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)., Phase I: Prevalence and incidence of anti-DYP688 antibodies., Phase I: Best Overall Response (BOR)., Phase I: Overall Response Rate (ORR) per RECIST v1.1., Phase II: Duration of response (DoR), progression free survival (PFS) and DCR per RECIST v1.1., Phase II: Overall survival (OS), Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, electrocardiograms (ECGs), and vital signs., Phase II: Frequency of dose interruptions, reductions, and discontinuations PK parameters for total mAb, conjugated active and inactive payload, and unconjugated active payloads (e.g., AUC, Cmax, CL, half-life)., Phase II: Prevalence and incidence of anti-DYP688 antibodies. | — |
Countries
France, Germany, Netherlands, Spain
Outcome results
None listed