A Study of TAS-120 in Patients With Advanced Solid Tumors

Summary

Participation Requirements

Description

Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017 Phase 1 Dose Expansion: (CLOSED) Up to approximately 185 patients will be enrolled among the 8 groups as outlined below: Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions. Group 2- CCA (iCCA or eCCA) with FGFR2 gene ...

Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017 Phase 1 Dose Expansion: (CLOSED) Up to approximately 185 patients will be enrolled among the 8 groups as outlined below: Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions. Group 2- CCA (iCCA or eCCA) with FGFR2 gene fusions that are chemotherapy naive or intolerant to first line chemotherapy (i.e., on chemotherapy regimen ≤ 1 cycle). Group 3 - CCA (iCCA or eCCA) with FGFR2 gene fusions treated with prior FGFR inhibitors. Group 4 - CCA (iCCA or eCCA) with other FGFR2 abnormalities, ie, gene mutations, rearrangements or amplifications. Group 5 - GBM or grade III glioma (i.e, anaplastic astrocytoma or anaplastic oliogodendroglioma) with FGFR gene fusions or activating mutations Group 6 - Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations. Group 7: Basket of tumor types with tumors harboring FGFR2 amplification (≥10 copies). Group 8 - Basket of tumor types (except CCA, brain tumors and advanced urothelial carcinomas) with tumors harboring FGFR gene fusions or activating mutations. Phase 2: Approximately 100 iCCA patients with confirmed FGFR2 gene fusions will be treated. Patients will be centrally screened for FGFR2 gene fusions. This is a Single arm study with the primary endpoint of ORR.

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