Overview

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

Status:
Completed
Trial end date:
2021-05-29
Target enrollment:
0
Participant gender:
All
Summary
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, PK, 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 MTD and/ or RP2D 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 CNS tumors, urothelial carcinoma, breast cancer, gastric cancer and 3. Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Taiho Oncology, Inc.
Treatments:
Futibatinib
Criteria
Inclusion Criteria:

1. Provide written informed consent

2. Age ≥ 18 years of age

3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer

4. 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 RANO
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)

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. Adequate organ function.

Exclusion Criteria:

1. History and/or current evidence of clinically significant non-tumor related alteration
of calcium-phosphorus homeostasis.

2. History and/or current evidence of clinically significant ectopic
mineralization/calcification.

3. History and/or current evidence of clinically significant retinal disorder

4. A serious illness or medical condition(s)

5. Pregnant or breast-feeding female