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Brief Title: First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin
Official Title: An Open-label, First-in-human, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate, BAY2287411 Injection, in Patients With Solid Tumors Known to Express Mesothelin
Study ID: NCT03507452
Brief Summary: 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR