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