Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
Checked against the public recordLast updated Sep 19, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Taiho Oncology, Inc.
- Interventions being studied
- Drug: Futibatinib and Binimetinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.