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Strategic decision by sponsor.
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Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Futibitanib in combination with binimetinib | Experimental | Dose escalation: Futibitanib in combination with binimetinib in patients with advanced cancer disease. Dose expansion: Futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Futibatinib and Binimetinib | Drug | Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) in Part 1 | Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities | 12 months |
| Objective Response Rate (ORR) in Part 2 | proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1. | approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032 | Plasma concentrations of futibatinib, binimetinib, and AR00426032 | approximately 24 months |
| PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles UCLA Cancer | Santa Monica | California | 90404 | United States | ||
| Community Cancer Center North |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42149426 | Derived | Rodon J, O'Neil B, Lim C, Ammakkanavar NR, Torrado C, Matsuoka K, Hirai H, Miura A, Anderson B, Jin L, Hangai N, Long A, Wacheck V, Rosen L. Preclinical and clinical evaluation of futibatinib in combination with binimetinib in patients with advanced cancer. Invest New Drugs. 2026 May 18. doi: 10.1007/s10637-026-01618-y. Online ahead of print. |
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Plasma concentrations of futibatinib, binimetinib, and AR00426032 |
| approximately 24 months |
| PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032 | Plasma concentrations of futibatinib, binimetinib, and AR00426032 | approximately 24 months |
| PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032 | Plasma concentrations of futibatinib, binimetinib, and AR00426032 | approximately 24 months |
| PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032 | Plasma concentrations of futibatinib, binimetinib, and AR00426032 | approximately 24 months |
| PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032 | Plasma concentrations of futibatinib, binimetinib, and AR00426032 | approximately 24 months |
| Duration of response (DOR) | DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death | approximately 24 months |
| Progression-free survival (PFS) | PFS is defined as the time from date of first dose to objectively documented progression of disease or death | approximately 24 months |
| Disease control rate (DCR) at 24 months | DCR is defined as the percentage of patients who have achieved a CR, PR, or SD. | approximately 24 months |
| Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0 | Evaluate safety and tolerability of futibatinib in combination with binimetinib based on treatment-emergent adverse events per CTCAE v5.0(including serious adverse events),clinical laboratory parameters, ECGs, and vital signs | Approximately 24 months |
| Indianapolis |
| Indiana |
| 46250 |
| United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000713257 | futibatinib |
| C581313 | binimetinib |
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