Last updated on December 2018

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


Brief description of study

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.

Detailed Study Description

Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017

Phase 1 Dose Expansion:

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.

Clinical Study Identifier: NCT02052778

Contact Investigators or Research Sites near you

Start Over

Patty Lynch

Massachusetts General Hospital
Boston, MA United States
  Connect »

Funda Meric-Bernstam

MD Anderson Cancer Center
Houston, TX United States
  Connect »

Jerry Huang, MD

Institute Goustave-Roussy
Paris, France
  Connect »

Tobias Arkenau

Sarah Cannon Research Institute
London, United Kingdom
  Connect »

Lisa Johnson

Greenville Health System ITOR
Greenville, SC United States
  Connect »

Jerry Huang, MD

Institut Bergonie
Bordeaux, France
  Connect »

Jerry Huang, MD

Centre L on B rard B t
Lyon, France
  Connect »

Marc Sanson

Piti -Salp tri re Hospital
Paris, France
  Connect »

Federico Longo

University Hospital Ram n y Cajal
Madrid, Spain
  Connect »

Valentina Boni

Centro Integral Oncol gico Clara Campal - Hospital Universitario Madrid Sanchinarro
Madrid, Spain
  Connect »

Brett Madden

Mayo Clinic (AZ)
Scottsdale, AZ United States
  Connect »

Daneng Li

City of Hope National Medical Center
Duarte, CA United States
  Connect »

Lillian Jahan

UCSF - Helen Diller
San Francisco, CA United States
  Connect »

Evans Pope

Mayo Clinic (Jacksonville)
Jacksonville, FL United States
  Connect »

Jerry Huang, MD

Florida Hospital
Orlando, FL United States
  Connect »

Toni Mangskau

Mayo Clinic (MN)
Rochester, MN United States
  Connect »

Ursa Brown-Glaberman

New Mexico Cancer Care Alliance
Albuquerque, NM United States
  Connect »

Jerry Huang, MD

Roswell Park Cancer Institute
Buffalo, NY United States
  Connect »

Jerry Huang, MD

University of Pennsylvania
Philadelphia, PA United States
  Connect »

Cynthia Perez

Sidney Kimmel Cancer Center at Jefferson
Philadelphia, PA United States
  Connect »

Mary Crowley Cancer Research

Mary Crowley
Dallas, TX United States
  Connect »

Ryan Sinit

Virginia Mason Cancer Center
Seattle, WA United States
  Connect »

Jerry Huang, MD

Royal Melbourne Hospital
Melbourne, Australia
  Connect »

Jerry Huang, MD

Hospices Civils de Lyon
Bron, France
  Connect »

Christelle Nicolle

Rennes, Centre Eug ne Marquis
Rennes cedex, France
  Connect »

Ignacio Matos

Val D'Hebron University Hospital
Barcelona, Spain
  Connect »

Dr Javier García-Corbacho

Hospital Clinic i Provincial de Barcelona,
Barcelona, Spain
  Connect »

Jerry Huang, MD

University College London Hospital
London, United Kingdom
  Connect »

Jerry Huang, MD

Scientia Clinical Research University of New South Wales
Randwick, Australia
  Connect »

Dr. Stephen Lam Chan

Prince of Wales Hospital
Shatin, Hong Kong
  Connect »

LaToya Berry

The University of Kansas Cancer Center
Westwood, KS United States
  Connect »

Cancer Connect

UW Carbone Cancer Center
Madison, WI United States
  Connect »

Rachel Hungerford, RN

Banner MD Anderson Cancer Center
Gilbert, AZ United States
  Connect »

Maria E Rivas

Cancer Treatment Centers of America Zion, IL
Zion, IL United States
  Connect »

Mary Linton Peters

Cancer Center at Beth Israel Deaconess Medical Center
Boston, MA United States
  Connect »

GI Clinical Research Line

Dana Farber Cancer Institution
Boston, MA United States
  Connect »

Amanda Newman

Wayne State Universtity (Karmanos Cancer Institute)
Detroit, MI United States
  Connect »

Ken Kuenzli, RN

Spartanburg Medical Center
Spartanburg, SC United States
  Connect »

Dr. Stephen Lam Chan

The Chinese University of Hong Kong
Sha Tin, Hong Kong
  Connect »

Takashi Mizuno

Nagoya University Hospital
Nagoya, Japan
  Connect »

Tatsuya Ioka

Osaka International Cancer Institute
Osaka, Japan
  Connect »

Su-Young Kim

ASAN Medical Center (Seoul)
Seoul, Korea, Republic of
  Connect »

Joon Oh Park, M.D., Ph.D

Samsung Medical Center (Seoul)
Seoul, Korea, Republic of
  Connect »

Dr. Do-Youn Oh

Seoul National University Hospital
Seoul, Korea, Republic of
  Connect »

Chih-Hung Hsu

National Taiwan University Hospital
Taipei, Taiwan
  Connect »

Dr. Debashis Sarker

Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
  Connect »

Becky Slawik

Cancer Treatment Centers of America
Newnan, GA United States
  Connect »

Paolo Casibang, RN

Cancer Treatment Centers of America Philadelphia, PA
Philadelphia, PA United States
  Connect »

Kimberly Auth

University of Pittsburgh Medical Center
Pittsburgh, PA United States
  Connect »

Hyun Jung Park

Yonsei University, Severance Hospital (Seoul)
Seoul, Korea, Republic of
  Connect »

Medical College of Wisconsin Clinical ...

Medical College of Wisconsin
Milwaukee, WI United States
  Connect »

HJ Klumpen

University of Amsterdam
Amsterdam, Netherlands
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.