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

Completed · Phase 1/Phase 2

Conditions studied: Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors, Primary CNS Tumors, Breast Cancer, Gastric Cancer

In brief

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, pharmacokinetic, 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 -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose 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 central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

Key facts

Study ID

NCT02052778

Run by

Taiho Oncology, Inc.

People needed

407

Starts

2014-07-21

Expected to finish

2024-10-22

Last updated by the study team

2025-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent
• Age ≥ 18 years of age
• Has histologically or cytologically confirmed, locally advanced or metastatic cancer
• The following specific criteria for each study portion
• Phase 1 (Dose Escalation):
• Patients with any type of solid tumor
• Disease progression following standard therapies or intolerant to prior standard therapies
• Phase 1 (Dose Expansion)
• Have at least one FGF/FGFR aberration
• Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors).
• Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or Response Assessment in Neuro-Oncology criteria (2010) for brain tumors.
• Patients with any of the following tumor types
• Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations
• Patients with primary CNS tumors
• Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
• Patients with breast cancer or gastric cancer
• Patients with other solid tumor types harboring FGFR gene fusions or activating mutations
• Patients with solid tumor types and other FGF/FGFR alterations not listed above
• Phase 2
• Patients with iCCA and FGFR2 gene rearrangements (incl fusions)
• Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy
• Must have documentation of radiographic progression of disease
• No prior FGFR inhibitor
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if…

• History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
• History and/or current evidence of clinically significant ectopic mineralization/calcification.
• History and/or current evidence of clinically significant retinal disorder
• A serious illness or medical condition(s)
• Pregnant or breast-feeding female

Where it is running

• Mayo Clinic (AZ) — Scottsdale, Arizona, United States
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay — San Francisco, California, United States
• Cancer Treatment Centers of America — Newnan, Georgia, United States
• Cancer Treatment Centers of America Zion, IL — Zion, Illinois, United States
• The University of Kansas Cancer Center — Fairway, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institution — Boston, Massachusetts, United States
• Wayne State Universtity (Karmanos Cancer Institute) — Detroit, Michigan, United States
• Mayo Clinic (MN) — Rochester, Minnesota, United States
• New Mexico Cancer Care Alliancer — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sidney Kimmel Cancer Center at Jefferson — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Greenville Health System ITOR,Clinical Research Unit — Greenville, South Carolina, United States
• Spartanburg Medical Center — Spartanburg, South Carolina, United States
• Mary Crowley Cancer Research - Medical City — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Virginia Mason Cancer Center — Seattle, Washington, United States
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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