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TerminatedPhase 1NCT04965818
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFutibatinib and Binimetinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 19, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Taiho Oncology, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Taiho Oncology, Inc.
Interventions being studied
Drug: Futibatinib and Binimetinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Los Angeles UCLA CancerSanta Monica, California
  • Community Cancer Center NorthIndianapolis, Indiana
  • The University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 19, 2024. Always confirm current availability with the study team.

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