A Study of TAS-120 in Patients With Advanced Solid Tumors
Status and phase
Completed
Phase 2
Phase 1
Conditions
Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors
Breast Cancer
Gastric Cancer
Urothelial Cancer
Primary CNS Tumors
Cholangiocarcinoma
Treatments
Drug: Futibatinib
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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:
- Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib.
- 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.
- Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Enrollment
407 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
-
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
-
Adequate organ function.
Exclusion criteria
- 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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
407 participants in 23 patient groups
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Experimental group
Description:
Participants with or without fibroblast growth factor \[FGF\]/fibroblast growth factor receptor \[FGFR\] gene abnormalities received orally TAS-120 8 milligrams (mg) orally every other day (QOD; Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Experimental group
Description:
Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Experimental group
Description:
Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Experimental group
Description:
Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Experimental group
Description:
Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Experimental group
Description:
Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QD Dosing: 4 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QD Dosing: 8 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QD Dosing: 16 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QD Dosing: 20 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Escalation: QD Dosing: 24 mg
Experimental group
Description:
Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion Cohort 1
Experimental group
Description:
Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Cohort 2
Experimental group
Description:
Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Cohort 3
Experimental group
Description:
Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Cohort 4
Experimental group
Description:
Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1:Dose Expansion: Cohort 5
Experimental group
Description:
Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Cohort 6
Experimental group
Description:
Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Sub-cohort 1
Experimental group
Description:
Participants with iCCA who were enrolled prior to the confirmation of the recommended Phase 2 dose (RP2D) received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 1: Dose Expansion: Sub-cohort 2
Experimental group
Description:
Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Phase 2
Experimental group
Description:
Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment:
Drug: Futibatinib
Trial contacts and locations
58
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Data sourced from clinicaltrials.gov
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