Advanced or metastatic solid tumors
Conditions
Brief summary
1. TEAEs including determination of DLTs and SAEs. AEs will be assessed, and severity assigned by using the NCI CTCAE v5.0., 2. Clinical response including ORR and DOR per RECIST v1.1 in colorectal adenocarcinoma and Ewing sarcoma.
Detailed description
1. PK parameters: AUC0-inf, AUC0-last, AUC0-21d or AUC0-28d (depending on dosing interval), Cmax, Ctrough, and Tmax will be estimated using standard non compartmental analysis (NCA) as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios [RCmax, RCtrough]) will be calculated if data permit., 2. Incidence, quantity, and effect of ADAs against INBRX-109., 3. Median PFS (colorectal adenocarcinoma and Ewing sarcoma).
Interventions
DRUGDEXAMETHASONE
DRUGCampto 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Sponsors
Inhibrx Biosciences Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. TEAEs including determination of DLTs and SAEs. AEs will be assessed, and severity assigned by using the NCI CTCAE v5.0., 2. Clinical response including ORR and DOR per RECIST v1.1 in colorectal adenocarcinoma and Ewing sarcoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK parameters: AUC0-inf, AUC0-last, AUC0-21d or AUC0-28d (depending on dosing interval), Cmax, Ctrough, and Tmax will be estimated using standard non compartmental analysis (NCA) as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios [RCmax, RCtrough]) will be calculated if data permit., 2. Incidence, quantity, and effect of ADAs against INBRX-109., 3. Median PFS (colorectal adenocarcinoma and Ewing sarcoma). | — |
Countries
France, Italy, Netherlands, Spain
Outcome results
None listed