Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer

  • STATUS
    Recruiting
  • End date
    Dec 13, 2024
  • participants needed
    36
  • sponsor
    Taiho Oncology, Inc.
Updated on 13 June 2022
measurable disease
KRAS

Summary

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

Description

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 and dosing schedule 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.

Details
Condition Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation
Treatment Futibatinib and Binimetinib
Clinical Study IdentifierNCT04965818
SponsorTaiho Oncology, Inc.
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
Current evidence or history 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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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