Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerPhase 2NCT05945823
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
A Phase 2 study testing Futibatinib, Pembrolizumab and Cisplatin in people with Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer and Esophageal Adenocarcinoma, run by Taiho Oncology, Inc. at 22 sites in 4 countries.
Trial summary
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer
- What is being tested?
- Futibatinib, Pembrolizumab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 13 Jul 2023to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Is ≥18 years of age at the time of informed consent
- Cohort A: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ).
- Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
- No prior systemic treatment for locally advanced, unresectable or metastatic disease
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Able to take medications orally
Who cannot join
- Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
- Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients).
- Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor.
- Has known additional malignancy that is progressing or requires active treatment.
- History or current evidence of calcium and phosphate homeostasis disorder
- Current evidence of clinically significant retinal disorder
Show all 13Show fewer
- Pregnant or lactating female.
- Has known hypersensitivity or severe reaction to any of the study drugs or their excipients.
- Has a diagnosis of immunodeficiency.
- Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
- Has had an allogenic tissue/organ transplant.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States16 sites
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Buffalo, New York, 14203
Gabrail Cancer Center Research LLC
Canton, Ohio, 44718
Dallas VA Medical Center
Dallas, Texas, 75216
Rocky Mountain Cancer Centers Midtown
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
The Minniti Center - Medical Oncology and Hematology
Mickleton, New Jersey, 08056
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone
New York, New York, 10016
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
University of California Los Angeles UCLA - Cancer Care - Santa Monica
Santa Monica, California, 90404
Virginia Mason Medical Center
Seattle, Washington, 98101
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
France2 sites
Centre Hospitalier Regional Universitaire de Lille
Lille, 59037
Centre Hospitalier Regional Universitaire Poitiers
Poitiers, 86000
Germany2 sites
Krankenhaus Nordwest gGmbH
Frankfurt, 60488
Universitaetsmedizin Mainz
Mainz, 55131
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Read the detailed description
Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.
- Conditions
- Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Siewert Type 1 GEJ Cancer, Pancreatic Cancer
- Being tested
- Futibatinib, Pembrolizumab, Cisplatin, 5-FU, Oxaliplatin
- Keywords
- Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer, pancreatic ductal adenocarcinoma, pancreatic cancer
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Pancreatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FutibatinibDrug
Also called TAS-120
TAS-120 20 mg tablets, oral; once daily
PembrolizumabDrug
Also called MK-3475, KEYTRUDA®
400 mg once every 6-week-cycle, via IV infusion.
CisplatinDrug
Also called PLATINOL®
80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy
5-FUDrug
Also called ADRUCIL®
4000 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m^2 Q2W via bolus IV infusion followed by 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.
OxaliplatinDrug
Also called ELOXATIN®
85 mg/m^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.
LeucovorinDrug
Also called calcium folinate, folinic acid, WELLCOVORIN®
400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.
LevoleucovorinDrug
Also called calcium levofolinate, levofolinic acid, FUSILEV®
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
IrinotecanDrug
150 mg/m^2 Q2W as part of mFOLFIRINOX chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Receives: Drug: Futibatinib; Drug: Pembrolizumab; Drug: Cisplatin; Drug: 5-FU; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Levoleucovorin |
| Cohort B | Experimental | Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Receives: Drug: Futibatinib; Drug: Pembrolizumab; Drug: 5-FU; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Levoleucovorin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by investigator assessment
Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment
Measured: 12 months
Secondary outcomes (5)
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.
Measured: 12 months
DoR per investigator assessment
defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
Measured: 12 months
DCR per investigator assessment
defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment
Measured: 12 months
PFS per investigator assessment
defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
Measured: 12 months
6-month PFS rate
defined as percentage of patients without disease progression within 6 months of enrollment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start13 Jul 2023
- Primary completion1 Oct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 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
- NCT05945823
- Sponsor's protocol ID
- TAS-120-206
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.
- ClinicalTrials.gov ID
- NCT05945823
- Acronym / sponsor ID
- TAS-120-206
- Conditions
- Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer, Esophageal Adenocarcinoma, Esophageal Squamous Cell Cancer, Siewert Type 1 GEJ Cancer, Pancreatic Cancer
- Keywords
- Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer, pancreatic ductal adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jul 2023 (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.
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
Detailed description
Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Futibatinib, Drug: Pembrolizumab, Drug: Cisplatin, Drug: 5-FU, Drug: Oxaliplatin, Drug: Leucovorin, Drug: LevoleucovorinPatients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). |
| Cohort B | Experimental | Drug: Futibatinib, Drug: Pembrolizumab, Drug: 5-FU, Drug: Oxaliplatin, Drug: Leucovorin, Drug: Levoleucovorin, Drug: IrinotecanPatients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is ≥18 years of age at the time of informed consent
- Cohort A: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ).
- Cohort B: Histologically or cytologically confirmed, locally advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.
- No prior systemic treatment for locally advanced, unresectable or metastatic disease
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Key exclusion criteria (13 listed)
- Has locally advanced disease that is resectable or potentially curable with radiation therapy (as determined by local investigator).
- Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients).
- Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor.
- Has known additional malignancy that is progressing or requires active treatment.
- History or current evidence of calcium and phosphate homeostasis disorder
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 |
|---|---|---|
| FutibatinibAlso: TAS-120TAS-120 20 mg tablets, oral; once daily | Drug | Cohort A, Cohort B |
| PembrolizumabAlso: MK-3475, KEYTRUDA®400 mg once every 6-week-cycle, via IV infusion. | Drug | Cohort A, Cohort B |
| CisplatinAlso: PLATINOL®80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy | Drug | Cohort A |
| 5-FUAlso: ADRUCIL®4000 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m^2 Q2W via bolus IV infusion followed by 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy. | Drug | Cohort A, Cohort B |
| OxaliplatinAlso: ELOXATIN®85 mg/m^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy. | Drug | Cohort A, Cohort B |
| LeucovorinAlso: calcium folinate, folinic acid, WELLCOVORIN®400 mg/m^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. | Drug | Cohort A, Cohort B |
| LevoleucovorinAlso: calcium levofolinate, levofolinic acid, FUSILEV®200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy. | Drug | Cohort A, Cohort B |
| Irinotecan150 mg/m^2 Q2W as part of mFOLFIRINOX chemotherapy. | Drug | Cohort B |
Primary outcome
ORR by investigator assessment
Time frame: 12 months
Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment
5 secondary outcomes
Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Time frame: 12 months
DoR per investigator assessment
Time frame: 12 months
DCR per investigator assessment
Time frame: 12 months
PFS per investigator assessment
Time frame: 12 months
6-month PFS rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Futibatinib, Pembrolizumab and Cisplatin in people with Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer and Esophageal Adenocarcinoma, run by Taiho Oncology, Inc. at 22 sites in 4 countries.
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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Germany, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
ORR by investigator assessment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.