Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Lee Rosen (ucla)

Description

Summary

Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.

Official Title

A Phase 1b/2 Open-label, Nonrandomized Study of FGFR Inhibitor Futibatinib in Combination With MEK-inhibitor Binimetinib in Patients With Advanced KRAS Mutant Cancer

Details

This is an open-label, nonrandomized, uncontrolled Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced KRASmt tumors. The study will consist of two parts: - Part 1: Dose-Escalation part to determine the RP2D of futibatinib in combination with binimetinib in patients with advanced cancer disease - Part 2: Dose-Expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC Patients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met.

Keywords

Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations Non-Small Cell Lung Cancer KRAS Gene Mutation Futibatinib Binimetinib MEKi FGFR FGFRi TAS-120 KRASmt NSCLC Carcinoma, Non-Small-Cell Lung Futibatinib and Binimetinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2)
  • Appropriate candidate for experimental therapy
  • For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate cardiac function (Left ventricular ejection fraction (LVEF) ≥50% )
  • Adequate organ function
  • Must have tumor tissue specimen available (optional for patients in Part 1)

You CAN'T join if...

  • History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
  • Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
  • Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures.
  • Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib
  • Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)

Locations

  • University of California Los Angeles UCLA Cancer accepting new patients
    Santa Monica California 90404 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UC Cancer

  • Lee Rosen (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 106 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT04965818
Phase
Phase 1/2
Study Type
Interventional
Last Updated