Advanced or Metastatic Solid TumorPhase 2NCT04189445
Futibatinib in Patients With Specific FGFR Aberrations
A Phase 2 study testing Futibatinib in people with Advanced or Metastatic Solid Tumor and Advanced or Metastatic Gastric or Gastroesophageal Cancer, run by Taiho Oncology, Inc. at 61 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN)
- What is being tested?
- Futibatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 61 sitesin 15 countries
- Study dates
- 5 Aug 2020to 11 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
- Cohort A
- Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Had disease progression/recurrence after standard treatment for their cancer
Show all 14Show fewer
- Cohort B
- Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification.
- Measurable disease per RECIST 1.1
- Received at least 2 prior systemic regimens for advanced/metastatic disease
- Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer
- Cohort C
- Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement
- Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies
Who cannot join
- History and/or current evidence of any of the following disorders:
- Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
- Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
- Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.
- Prior treatment with an FGFR inhibitor
- Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)
Trial locations and contacts
61 sites in 15 countries.
61 sites in 15 countries
United States11 sites
University of Maryland
Baltimore, Maryland, 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
Houston Methodist Cancer Center
Houston, Texas, 77030
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90404
Mercy Clinic Oncology and Hematology - Coletta
Oklahoma City, Oklahoma, 73120
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 53705
Georgetown University - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Henry Ford Hospital
Woodhaven, Michigan, 48183
France8 sites
Institut Bergonié
Bordeaux, Gironde, 33076
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079
Centre Léon Bérard
Lyon, Rhone, 69008
Centre Antoine Lacassagne
Nice, Alpes Maritimes, 06200
Hôpital Saint-Louis
Paris, Paris, 75475
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495
Centre Paul Strauss
Strasbourg, Bas Rhin, 67000
Institut Gustave Roussy
Villejuif, Val De Marne, 94805
Spain8 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario HM Madrid Sanchinarro
Madrid, 28050
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Universitario Virgen Macarena
Seville, 41009
Instituto Valenciano de Oncologia IVO
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Japan6 sites
National Cancer Center Hospital
Chūōku, Tokyo-To, 104-0045
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Italy5 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Forli - Cesena, 47014
IEO Istituto Europeo di Oncologia
Milan, 20141
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)
Verona, 37124
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Germany3 sites
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50924
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Portugal3 sites
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisbon, 1169-050
Fundação Champalimaud
Lisbon, 4099-001
Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio
Porto, 4099-001
Turkey (Türkiye)3 sites
Acibadem Adana Hospital
Adana, 01130
Acibadem Maslak Hospital
Istanbul, 34457
Namik Kemal University
Tekirdağ, 59100
Hong Kong2 sites
The University of Hong Kong
Hong Kong
Hong Kong United Oncology Centre
Jordon, 0000
Netherlands2 sites
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
Erasmus Medisch Centrum
Rotterdam, 3015 AA
Sweden2 sites
Karolinska universitetssjukhuset - Solna
Solna, 171 64
Akademiska Sjukhuset
Uppsala, 75185
United Kingdom1 site
Sarah Cannon Research Institute UK
London, Greater London, W1G 6AD
About this study
Official title: A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations
The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.
Read the detailed description
Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.
Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.
The study will enroll approximately:
- Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;
- Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;
- Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements
Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).
Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.
Additional cohorts may be added in the future in case of new emerging efficacy data.
- Conditions
- Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN)
- Being tested
- Futibatinib
- Keywords
- Futibatinib, Gastric cancer, Gastro-esophageal junction cancer, Solid tumor, Myeloid neoplasm, Lymphoid neoplasm, FGFR, Amplification, Rearrangement, TAS-120
- Medical subject headings
- Neoplasm Metastasis, Stomach 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
Futibatinib tablets were dosed orally every day on a continuous 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Futibatinib (Cohort A) | Experimental | Participants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. Receives: Drug: Futibatinib |
| Futibatinib (Cohort B) | Experimental | Participants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. Receives: Drug: Futibatinib |
| Futibatinib (Cohort C) | Experimental | Participants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. Receives: Drug: Futibatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B
ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
Complete Response (CR) Rate in Cohort C
CR rate was defined as the percentage of participants who achieved a CR (per response criteria for myeloid or lymphoid neoplasm) based on investigator assessment of imaging, peripheral blood, and bone marrow. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
Secondary outcomes (16)
ORR Based on Investigator Assessment in Cohorts A and B
ORR was defined as the percentage of participants experiencing a best overall response of PR or CR (per RECIST 1.1), based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
Duration of Response (DOR) Based on IRC in Cohorts A, B and C
DOR was defined as the time from the first documentation of response (CR or PR in based on IRC) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
DOR Based on Investigator Assessment in Cohorts A, B and C
DOR was defined as the time from the first documentation of response (CR or PR in based on Investigator Assessment) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on IRC), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
PFS Based on Investigator Review in Cohorts A, B and C
PFS was defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression (based on Investigator Review), whichever occurs first. The PFS was analyzed using a Kaplan-Meier method, with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
Overall Survival (OS) in Cohorts A, B and C
OS was defined as the time from the date of first dose to the death date. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure.
Measured: Up to 31 months
Disease Control Rate (DCR) Based on IRC in Cohort A and B
DCR was defined as the percentage of participants experiencing a best overall response of stable disease (SD), PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
DCR Based on Investigator Review in Cohort A and B
DCR was defined as the percentage of participants experiencing a best overall response of SD, PR, or CR (per RECIST 1.1), based on IRC. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of target lesion diameters from the smallest on study (including baseline), with an absolute increase of ≥ 5 mm, or the appearance of new lesions. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. Percentages were rounded off to the nearest single decimal place.
Measured: At the end of every 2 cycles until disease progression (Up to 31 months)
CR+ Complete Response With Incomplete Hematological Recovery (CRi) Rate in Cohort C
CR+CRi rate was defined as the percentage of participants who achieved a CR or CRi.
Measured: Up to 31 months
Duration of CR in Cohort C
Duration of CR was defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.
Measured: Up to 31 months
Duration of CR+CRi in Cohort C
Duration of CR+CRi was defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.
Measured: Up to 31 months
Complete Cytogenetic Response (CCyR) Rate in Cohort C
CCyR rate was defined as the percentage of participants who achieved a CCyR.
Measured: Up to 31 months
Partial Cytogenetic Response (PCyR) Rate in Cohort C
PCyR rate was defined as the percentage of participants who achieved a PCyR.
Measured: Up to 31 months
Relapse-free Survival (RFS) in Cohort C
RFS was defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first.
Measured: Up to 31 months
Event-free Survival (EFS) in Cohort C
EFS was defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or participant death due to any cause, whichever occurs first.
Measured: Up to 31 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and C
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. A treatment-emergent AE (TEAE) is defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug, and does not necessarily have a causal relationship to the use of the study drug.
Measured: From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start5 Aug 2020
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Why it stopped: Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts
- Masking
- None (open label)
- Enrolment
- 115 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
- NCT04189445
- Sponsor's protocol ID
- TAS-120-202
- Other IDs
- 2019-004084-49, 2019
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2019
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations
- ClinicalTrials.gov ID
- NCT04189445
- Acronym / sponsor ID
- TAS-120-202
- Conditions
- Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN)
- Keywords
- Futibatinib, Gastric cancer, Gastro-esophageal junction cancer, Solid tumor, Myeloid neoplasm, Lymphoid neoplasm, FGFR, Amplification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.
Detailed description
Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status.
Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle.
The study will enroll approximately:
- Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA;
- Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification;
- Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements
Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first).
Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor.
Additional cohorts may be added in the future in case of new emerging efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of independent 3 cohorts (Cohorts A, B and C) and there is no difference in the treatment regimen between the cohorts
| Arm | Type | Receives |
|---|---|---|
| Futibatinib (Cohort A) | Experimental | Drug: FutibatinibParticipants with advanced or metastatic solid tumors harboring FGFR1-4 rearrangements received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 841 days. |
| Futibatinib (Cohort B) | Experimental | Drug: FutibatinibParticipants with advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification received futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle up to a maximum of 297 days. |
| Futibatinib (Cohort C) | Experimental | Drug: FutibatinibParticipants with myeloid or lymphoid neoplasm harboring FGFR1 rearrangement were to receive futibatinib 20 mg, oral tablets, once a day on a continuous 28-day cycle until disease progression, unacceptable toxicity or other treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Had disease progression/recurrence after standard treatment for their cancer
- Cohort B
Key exclusion criteria (6 listed)
- History and/or current evidence of any of the following disorders:
- Prior treatment with an FGFR inhibitor
- Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)
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-120Futibatinib tablets were dosed orally every day on a continuous 28-day cycle | Drug | Futibatinib (Cohort A), Futibatinib (Cohort B), Futibatinib (Cohort C) |
Primary outcome
Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
ORR was defined as the percentage of participants experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on IRC of radiological images. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place.
Complete Response (CR) Rate in Cohort C
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
CR rate was defined as the percentage of participants who achieved a CR (per response criteria for myeloid or lymphoid neoplasm) based on investigator assessment of imaging, peripheral blood, and bone marrow. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.
16 secondary outcomes
ORR Based on Investigator Assessment in Cohorts A and B
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
Duration of Response (DOR) Based on IRC in Cohorts A, B and C
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
DOR Based on Investigator Assessment in Cohorts A, B and C
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
Progression- Free Survival (PFS) Based on IRC in Cohorts A, B and C
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
PFS Based on Investigator Review in Cohorts A, B and C
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
Overall Survival (OS) in Cohorts A, B and C
Time frame: Up to 31 months
Disease Control Rate (DCR) Based on IRC in Cohort A and B
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
DCR Based on Investigator Review in Cohort A and B
Time frame: At the end of every 2 cycles until disease progression (Up to 31 months)
CR+ Complete Response With Incomplete Hematological Recovery (CRi) Rate in Cohort C
Time frame: Up to 31 months
Duration of CR in Cohort C
Time frame: Up to 31 months
Duration of CR+CRi in Cohort C
Time frame: Up to 31 months
Complete Cytogenetic Response (CCyR) Rate in Cohort C
Time frame: Up to 31 months
Partial Cytogenetic Response (PCyR) Rate in Cohort C
Time frame: Up to 31 months
Relapse-free Survival (RFS) in Cohort C
Time frame: Up to 31 months
Event-free Survival (EFS) in Cohort C
Time frame: Up to 31 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) - Cohort A, B and C
Time frame: From the first dose of study drug up to 30 days after the last dose (Up to 31 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
61 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Futibatinib in people with Advanced or Metastatic Solid Tumor and Advanced or Metastatic Gastric or Gastroesophageal Cancer, run by Taiho Oncology, Inc. at 61 sites in 15 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 14 inclusion and 6 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, France, Spain, Japan, Italy and 10 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B (time frame: At the end of every 2 cycles until disease progression (Up to 31 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?
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 8 Oct 2025.