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

Stopped early · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation

In brief

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

Key facts

Study ID

NCT04965818

Run by

Taiho Oncology, Inc.

People needed

38

Starts

2021-09-20

Expected to finish

2023-09-21

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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)

Where it is running

• University of California Los Angeles UCLA Cancer — Santa Monica, California, United States
• Community Cancer Center North — Indianapolis, Indiana, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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