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Advanced Solid Tumors w/ FGF/FGFR Aberrations (TPU-TAS-120-101)

Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

Objective

Overview

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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting the following criteria:

Phase 1 Expansion

  1. Patient has failed all standard therapies or standard therapy does not exist or is not tolerated.
  2. Patient has specific FGF/FGFR aberrations

    • Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or amplifications
    • Glioblastoma or grade III glioma (i.e., anaplastic astrocytoma or anaplastic oligodendroglioma) with FGFR gene fusions or activating mutations.
    • Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
    • All other tumor types harboring FGF9, FGF19 or FGFR2 amplifications (≥ 10 copies), FGFR gene fusions, or FGFR activating mutations

Phase 2

  1. Patient has histologically or cytologically confirmed, locally advanced, metastatic, unresectable iCCA harboring FGFR2 gene fusions based on results from a NGS assay by the Sponsor's designated central laboratory
  2. Patient has been treated with and failed at least one prior systemic gemcitabine and platinum-based chemotherapy for the advanced disease
  3. Must have documentation of radiographic progression of disease on prior systemic therapy
  4. Patient has 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.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Adequate organ function

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

A patient will be excluded from this study if any of the following criteria are met:

  • History and/or current evidence of 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 confirmed by retinal examination.
  • A serious illness or medical condition(s)

Phase: I/II

Learn More

ClinicalTrials.Gov

IRB Protocol Number
TPU-TAS-120-101
Principal Investigator(s)
Vikas Dembla, M.D.

Clinical Trial Categories

  • Phase I
  • Precision Medicine & Rare Tumors
  • Oncology
  • Gastrointestinal Cancer
  • Genitourinary Cancer
  • Neurologic Cancer
Contact
Kenneth A. Kuenzli II, RN at 864-560-7579
or kkuenzli@gibbscc.org
How to Participate

Kenneth A. Kuenzli II, RN
864-560-7579
kkuenzli@gibbscc.org

Location

  • Gibbs Cancer Center & Research Institute – Spartanburg
    380 Serpentine Drive
    Spartanburg, SC 29303

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