A Study of TAS-120 in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2021-05-29
Target enrollment:
Participant gender:
Summary
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor
receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the
safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients
with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be
conducted in 3 parts:
1. Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in
patients with tumors harboring FGF/FGFR aberrations, including patients with
cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer,
gastric cancer and
3. Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with
tumors harboring FGFR2 gene rearrangements (incl fusions).