Advanced Solid Tumors
Conditions
Brief summary
Documentation of AEs and SAEs (graded according to the NIH National Cancer Institute, Division of Cancer Treatment and Diagnosis: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or higher, clinically significant laboratory parameters and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration., In Phase 1, identify DLT occurrence: Determination of signal-seeking dose and the MTD or maximum administered dose of BI-1206, based on the modified mTPI-2 design., In Phase 2a: Determination of the RP2D
Detailed description
Determination of standard PK parameters (i.e., AUC, Cmax, Tmax, and terminal half-life [t½]) for BI-1206., Measurement of ADA response to BI-1206., Blood exploratory samples. Measurement of CD32b receptor occupancy on B cells.
Interventions
DRUGBI-1206
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
BioInvent International AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of AEs and SAEs (graded according to the NIH National Cancer Institute, Division of Cancer Treatment and Diagnosis: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or higher, clinically significant laboratory parameters and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration., In Phase 1, identify DLT occurrence: Determination of signal-seeking dose and the MTD or maximum administered dose of BI-1206, based on the modified mTPI-2 design., In Phase 2a: Determination of the RP2D | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of standard PK parameters (i.e., AUC, Cmax, Tmax, and terminal half-life [t½]) for BI-1206., Measurement of ADA response to BI-1206., Blood exploratory samples. Measurement of CD32b receptor occupancy on B cells. | — |
Countries
Germany, Poland, Romania, Spain, Sweden
Outcome results
None listed