A Phase 1/1b Open-label Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Anti-tumor Activity of KIN-3248 in Participants with Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations

Brief description of study

This study is designed for patients who have Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations. This study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of KIN-3248, a next-generation, irreversible, small molecule pan-fibroblast growth factor receptor (FGFR) inhibitor. This study will determine a recommended Phase 2 dose (RP2D) of KIN-3248 for further clinical development and assess the objective response to KIN-3248 therapy in participants with advanced tumors harboring pertinent FGFR2 and/or FGFR3 gene alterations.. This is also a first in human (FIH), two-part, open-label, multicenter, dose escalation and dose expansion study.


Clinical Study Identifier: s22-00567
Principal Investigator: Kristen Spencer.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Scot Niglio, Janice Mehnert, Maya Dimitrova, Elizabeth Kathleen Job, Jeffrey S. Weber, Jessica Wang, Jonathan B Kahn, Christy Lynn Spalink, Joshua K Sabari, Keriann M Scavone, Cosmin Adrian Tegla, Nina Beri, Caitlin Elizabeth Ryan, David R. Wise, Salman Rafi Punekar, Carol M Lee, Elise M Zahriah, Zujun Li, Samantha VanMaanen, Kathleen M Madden, Ann M Riccobene, Douglas K Marks.


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