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Advanced CholangiocarcinomaPhase 2FOENIX-CCA4NCT05727176

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

A Phase 2 study testing TAS-120 in people with Advanced Cholangiocarcinoma and FGFR2 Fusions, run by Taiho Oncology, Inc. at 65 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAS-120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
65 sitesin 13 countries
Study dates
5 Jul 2023to Dec 2026
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

  • Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
  • Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
  • Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
  • Documentation of radiographic disease progression on the most recent prior therapy
  • Measurable disease
  • performance status 0 or 1
  • Adequate organ function

Who cannot join

  • History or current evidence of calcium and phosphate homeostasis disorder
  • Current evidence of clinically significant retinal disorder
  • Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
  • Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
  • Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
  • Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
Show all 17Show fewer
  • Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.
  • Patients with prior FGFR-directed therapy
  • A serious illness or medical condition(s) including (but not limited to) the following:
  • Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
  • Known acute systemic infection
  • Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV New York Heart Association [NYHA] Classification) within the previous 2 months; if >2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
  • Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.
  • Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
  • Pregnant or lactating female.
  • Known hypersensitivity or severe reaction to futibatinib or its excipients.

Trial locations and contacts

65 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Taiho Oncology, INC contact

+1 844-878-2446

medicalinformation@taihooncology.com

65 sites in 13 countries

United States10 sites

  • Texas Oncology

    Abilene, Texas, 79606-5208

    Completed

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Withdrawn

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

    Completed

  • Texas Oncology Methodist DFW

    Dallas, Texas, 75230

    Completed

  • Texas Onc Methodist (Charlton)

    Dallas, Texas, 75237

    Completed

  • Texas Oncology - Northeast

    Denton, Texas, 76201

    Completed

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Completed

  • Center for Oncology and Blood Disorders

    Houston, Texas, 77030

    Withdrawn

  • University of California San Diego UCSD - Moores Cancer Center

    La Jolla, California, 92093

    Completed

  • Tampa General Hospital Cancer Institute

    Tampa, Florida, 33606

    Withdrawn

Other trials in United States

China10 sites, 10 recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130028

    0431-80596315, chengying@csco.org.cn

    Ying Cheng

    Recruiting

  • West China Hospital- Sichuan University

    Chengdu, Sichuan, 610041

    18980605963, caodan@wchscu.cn

    Dan Cao

    Recruiting

  • Guangdong Provincial People's Hospitall

    Guangzhou, Guangdong, 510080

    020-81884713, madong8005@126.com

    Dong Ma

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310016

    13605716662, shonco@sina.com

    Hongming Pan

    Recruiting

  • Harbin Medical University - Cancer Hospital

    Harbin, Heilongjiang

    13945095085, byxlcyj@126.com

    Yuxian Bai

    Recruiting

  • Shandong University - Shandong Cancer Hospital

    Jinan, Shandong, 250117

    15318816098, dangqi123456@126.com

    Qi Dang

    Recruiting

  • Jiangsu Provance Hospital

    Nanjing, Jiangsu, 212028

    Recruiting

  • Zhongahan Hospital Fudan unversity

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • Shanghai Gobroad Cancer Hospital China Pharmaceutical University

    Shanghai, 200123

    13661222111, lijin@csco.org.cn

    Jin Li

    Recruiting

  • Tongji University Shanghai East Hospital

    Shanghai

    Recruiting

Other trials in China

South Korea7 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Completed

  • Dong-A University Hospital

    Busan, 49201

    Withdrawn

  • Kyungpook National University Hospital

    Daegu, 41944

    Withdrawn

  • Gyeongsang National University Hospital

    Jinju, 52727

    Withdrawn

  • CHA Bundang Medical Center

    Seongnam, 13532

    Completed

  • Yonsei University Health System - Severance Hospital

    Seoul, 03722

    Completed

  • The Catholic University of Korea, St. Mary's Hospital

    Seoul, 06591

    Completed

Other trials in South Korea

Spain7 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Completed

  • Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals

    Barcelona, 08908

    Completed

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Completed

  • Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)

    Madrid, 28027

    Withdrawn

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid, 28040

    Completed

  • Hospital Universitario 12 de octubre

    Madrid, 28043

    Completed

  • Clinica Universidad de Navarra

    Pamplona, 31008

    Completed

Other trials in Spain

Brazil5 sites

  • Instituto do Cancer do Estado de Sao Paulo

    Cerqueira César, 01246-000

    Completed

  • IOP - Instituto de Oncologia do Parana

    Curitiba, 80530-010

    Completed

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

    Withdrawn

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

    Completed

  • Fundacao Antonio Prudente - A.C.Camargo Cancer Center

    São Paulo, 01508-010

    Completed

Other trials in Brazil

Japan5 sites

  • National Cancer Center Hospital East

    Kashiwa-Shi, 277-0882

    Completed

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Withdrawn

  • Nagoya University Hospital

    Nagoya, 466-8560

    Completed

  • Osaka Metropolitan University Hospital

    Osaka-Fu, 558-8585

    Completed

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Withdrawn

Other trials in Japan

Canada4 sites

  • Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)

    Kitchener, OH, N2G 1G3

    Withdrawn

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

    Withdrawn

  • Sunnybrook Health Sciences Center

    Toronto, Ohio, M4M 3N5

    Withdrawn

  • University of Toronto

    Toronto, OH, M5G 2M9

    Completed

Other trials in Canada

Poland4 sites

  • Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

    Koszalin, 75-581

    Withdrawn

  • Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli

    Lublin, 20-0920

    Withdrawn

  • Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.

    Otwock, 05-400

    Completed

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie

    Warsaw, 02-034

    Completed

Other trials in Poland

Argentina3 sites

  • Hospital Britanico

    Buenos Aires, AEB1280

    Completed

  • CEMIC

    CABA, 1431

    Completed

  • Sanatorio de la Mujer

    Rosario, S2013

    Withdrawn

Other trials in Argentina

Australia3 sites

  • Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center

    Melbourne, Victoria, 3004

    Completed

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

    Completed

  • St Vincent's Hospital Sydney - The Kinghorn Cancer Centre

    Sydney, New South Wales, 2010

    Completed

Other trials in Australia

Italy3 sites

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138

    Completed

  • IRCCS Humanitas Research Hospital

    Rozzano, 20089

    Completed

  • AOUI Verona - Ospedale Borgo Roma

    Verona, 37134

    Completed

Other trials in Italy

Hong Kong2 sites

  • The University of Hong Kong

    Hong Kong Island, 999077

    Withdrawn

  • The Chinese University of Hong Kong Prince of Wales Hospital

    New Territories, 999077

    Completed

Other trials in Hong Kong

Portugal2 sites

  • Fundação Champalimaud

    Lisbon, 1400-038

    Withdrawn

  • Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria

    Lisbon, 1649-035

    Withdrawn

Other trials in Portugal

About this study

Official title: Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.

Read the detailed description

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements. Eligible patients will be randomized on a 1:1 basis to the following study arms:

  • Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle.
  • Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.

Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first.

Being tested
TAS-120
Keywords
Futibatinib, Advanced cholangiocarcinoma, cholangiocarcinoma, FGFR2, Fusion, Rearrangemen, TAS-120
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS-120Drug

    Also called Futibatinib

    TAS-120 is an oral FGFR inhibitor

Study groups in NCT05727176
Study groupRoleWhat they receive
Treatment Arm AExperimentalTAS-120 (20mg) tablets, oral; 21-day cycle
Receives: Drug: TAS-120
Treatment Arm BExperimentalTAS-120 (16mg) tablets, oral; 21-day cycle
Receives: Drug: TAS-120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR by independent central review

    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 ICR

    Measured: 12 months after the study completion

Secondary outcomes (9)

  1. DoR by independent review

    defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first

    Measured: up to 12 months after the study completion

  2. PFS by independent review

    defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first

    Measured: up to 12 months after the study completion

  3. ORR per Investigator assessment

    defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).

    Measured: up to 12 months after the study completion

  4. 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: up to 12 months after the study completion

  5. PFS per Investigator assessment

    defined as the time from date of randomization to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first

    Measured: up to 12 months after the study completion

  6. OS

    defined as the time from the date of randomization until the date of death due to any cause.

    Measured: up to 12 months after the study completion

  7. 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. including serious adverse events (SAEs) and dose modifications.

    Measured: up to 12 months after the study completion

  8. Change from Baseline in Quality of life as assessed by EORTC QLQ-C30

    Change from Baseline in quality of life as assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

    Measured: up to 12 months after the study completion

  9. Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )

    Change from Baseline in Quality of Life as Assessed by European Quality of Life - 5 Dimensions-3 Levels (EQ-5D-3L) Scale Score.

    Measured: up to 12 months after the study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start5 Jul 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727176
Sponsor's protocol ID
TAS-120-205
Other IDs
2023-503665-39, 2022-9400, 2023
Acronym
FOENIX-CCA4
Status last verified
Aug 2026
First submitted
23 Jan 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAS-120 in people with Advanced Cholangiocarcinoma and FGFR2 Fusions, run by Taiho Oncology, Inc. at 65 sites in 13 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 7 inclusion and 17 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: looking for participants now, 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 65 sites in United States, China, South Korea, Spain, Brazil and 8 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?

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?

Contact Taiho Oncology, INC (+1 844-878-2446, medicalinformation@taihooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by independent central review (time frame: 12 months after the study completion). 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 NCT05727176.

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.

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