Advanced or Metastatic Solid Tumors Irrespective of Gene AlterationsPhase 1NCT04965818
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
A Phase 1 study testing Futibatinib and Binimetinib in people with Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations and Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc. at 3 sites in United States.
Trial summary
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation
- What is being tested?
- Futibatinib and Binimetinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Sep 2021to 21 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Community Cancer Center North
Indianapolis, Indiana, 46250
University of California Los Angeles UCLA Cancer
Santa Monica, California, 90404
About this study
Official title: 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
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
Read the 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
- Being tested
- Futibatinib and Binimetinib
- Keywords
- Futibatinib, Binimetinib, MEKi, FGFR, FGFRi, TAS-120, KRASmt, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Futibatinib and BinimetinibDrug
Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Futibatinib and Binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D) in Part 1
Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities
Measured: 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.
Measured: approximately 24 months
Secondary outcomes (10)
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: approximately 24 months
PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: approximately 24 months
PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: approximately 24 months
PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: approximately 24 months
PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: approximately 24 months
PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032
Plasma concentrations of futibatinib, binimetinib, and AR00426032
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start20 Sep 2021
- Primary completion11 Jun 2023
- Study completion21 Sep 2023
Why it stopped: Strategic decision by sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced or Metastatic Solid Tumors Irrespective of Gene AlterationsStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965818
- Sponsor's protocol ID
- TAS-120-204
- Status last verified
- Sep 2024
- First submitted
- 6 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 42149426
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04965818
- Acronym / sponsor ID
- TAS-120-204
- Conditions
- Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation
- Keywords
- Futibatinib, Binimetinib, MEKi, FGFR, FGFRi, TAS-120, KRASmt, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision by sponsor.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Futibitanib in combination with binimetinib | Experimental | Drug: Futibatinib and BinimetinibDose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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% )
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Futibatinib and BinimetinibPatients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle | Drug | Futibitanib in combination with binimetinib |
Primary outcome
Recommended Phase 2 Dose (RP2D) in Part 1
Time frame: 12 months
Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities
Objective Response Rate (ORR) in Part 2
Time frame: approximately 24 months
proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1.
10 secondary outcomes
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032
Time frame: approximately 24 months
Duration of response (DOR)
Time frame: approximately 24 months
Progression-free survival (PFS)
Time frame: approximately 24 months
Disease control rate (DCR) at 24 months
Time frame: approximately 24 months
Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: Approximately 24 months
Results and safety
The study was stopped early (reason given: Strategic decision by sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42149426Rodon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Futibatinib and Binimetinib in people with Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations and Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic decision by sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) in Part 1 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.