The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: * safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug) * tolerability (the degree to which side effects can be tolerated by your body) * maximum tolerated dose * pharmacokinetics (the effect of your body on the study drug) * anti-tumor activity * recommended dose for further clinical development
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Dose Escalation part: A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Dose Expansion part: The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
National Cancer Institute - Maryland
Bethesda, Maryland, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
HUS, Meilahden sairaala
Helsinki, Finland
Nederlands Kanker Instituut
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Skånes Universitetssjukhus
Lund, Sweden
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom
Incidence of DLTs (dose-limiting toxicity)
Time frame: 6 weeks (42 days)
Proportion of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and serious adverse events (SAEs)
Time frame: 6 months after the end of treatment
Cmax of Thorium-227 after single dose of Cycle 1
Time frame: From Day 1 to 43
Cmax of Radium-223 after single dose of Cycle 1
Time frame: From Day 1 to 43
Cmax of Total antibody after single dose of Cycle 1
Time frame: From Day 1 to 43
AUC(0-42 days) of Radium-223 after single dose of Cycle 1
Time frame: From Day 1 to 43
AUC(0-42 days) of Total antibody after single dose of Cycle 1
Time frame: From Day 1 to 43
AUC(0-42 days) of Thorium-227 after single dose of Cycle 1
Time frame: From Day 1 to 43
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.