Trials / Terminated
TerminatedNCT04965818
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
A Phase 1b/2 Open-label, Nonrandomized Study of FGFR Inhibitor Futibatinib in Combination With MEK-inhibitor Binimetinib in Patients With Advanced KRAS Mutant Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Taiho Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
Detailed 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. No patients were enrolled in Phase 2 as the Sponsor decided to not proceed with the dose expansion Phase 2 part of the TAS-120-204 study.
Conditions
- Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations
- Non-Small Cell Lung Cancer
- KRAS Gene Mutation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Futibatinib and Binimetinib | Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle |
Timeline
- Start date
- 2021-09-20
- Primary completion
- 2023-06-11
- Completion
- 2023-09-21
- First posted
- 2021-07-16
- Last updated
- 2024-09-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04965818. Inclusion in this directory is not an endorsement.