Phase 1 First-In-Human Study to Explore the Safety Tolerability and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Brief description of study
The tumor-associated antigens mesothelin (MSLN) and cadherin-3 (CDH3) are co-expressed in multiple tumor types, with minimal overlap observed in normal tissues. AMG 305 is a first dual-targeting BiTE (dBiTE™) molecule (CDH3-MSLN half-life extended [HLE] dBiTE™ AND dual targeting, HLE BiTE molecule) that targets the antigens P-cadherin (CDH3) and MSLN as well as CD3 on T-cells. AMG 305 is designed to increase the therapeutic index in solid tumors by preferentially targeting tumor cells that co-express CDH3 and MSLN over normal cells that express only 1 of these targets.
Clinical Study Identifier: s22-01463
ClinicalTrials.gov Identifier: NCT05800964
Principal Investigator:
Sally Lau.
Other Investigators:
Nila Theresa De La Rosa,
Scot Niglio,
Samantha VanMaanen,
Nancy Chan,
Jessica Wang,
Kathleen M Madden,
Elaine Shum,
Ann M Riccobene,
Kristen Spencer,
Salman Rafi Punekar,
Joshua K Sabari,
Keriann M Scavone,
Elise M Zahriah,
Kirby Rodriguez,
Nina Beri,
Paul E. Oberstein,
Caitlin Elizabeth Ryan,
Zujun Li,
Eneil De La Pena,
Janice Mehnert,
Douglas K Marks.
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