Open Actively Recruiting

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

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 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)

Join this Trial

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Study Stats
Protocol No.
21-000722
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04965818
For detailed technical eligibility, visit ClinicalTrials.gov.