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

  • STATUS
    Not Recruiting
  • participants needed
    371
  • sponsor
    Taiho Oncology, Inc.
Updated on 26 July 2021
cancer
measurable disease
carcinoma
metastasis
gemcitabine
glioblastoma multiforme
astrocytoma
anaplastic astrocytoma
FGFR2
metastatic cancer
transitional cell carcinoma
extrahepatic cholangiocarcinoma
advanced urothelial carcinoma
fgf19

Summary

This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities.

The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas , urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion; and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.

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 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.

Details
Condition Adenocarcinoma, Cholangiocarcinoma, Multiple Myeloma, Malignant neoplasm of brain, Brain Tumor (Pediatric), Solid Tumors, Urothelial Cancer, Other Tumor Types With FGFR2 Gene Fusions, Activating Mutations, FGFR2 Amplification, Brain Cancer, Malignant Adenoma, Brain Tumor
Treatment TAS-120
Clinical Study IdentifierNCT02052778
SponsorTaiho Oncology, Inc.
Last Modified on26 July 2021

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