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AzTrials

Biliary Tract CancerPhase 3FOENIX-BTCNCT07710885

Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

A Phase 3 study testing Futibatinib, Zimberelimab and Durvalumab in people with Biliary Tract Cancer, run by Taiho Pharmaceutical Co., Ltd. at 21 sites in 4 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

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Futibatinib, Zimberelimab and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
784 participants
Where
21 sitesin 4 countries
Study dates
24 Jun 2026to 31 Dec 2031
Phase
Phase 3
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

  • Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;
  • Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);
  • Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.
  • Has radiographically measurable disease per RECIST v1.1.
  • Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
  • Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Who cannot join

  • History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
  • History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
  • Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
  • Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Trial locations and contacts

21 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Kotaro Suto contact

+81-3-3294-4527

th-FOENIX-BTC-Clin.Dev@taiho.co.jp

21 sites in 4 countries

Japan11 sites, 11 recruiting

  • Research Site

    Aichi

    Not yet recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka

    Recruiting

  • Research Site

    Fukuoka

    Not yet recruiting

  • Research Site

    Hokkaido

    Not yet recruiting

  • Kanagawa Cancer Center

    Kanagawa

    Not yet recruiting

  • Research Site

    Miyagi

    Not yet recruiting

  • Research Site

    Osaka

    Not yet recruiting

  • Research Site

    Tokyo

    Not yet recruiting

  • The Cancer Institute Hospital

    Tokyo

    Recruiting

  • Toyama University Hopspital

    Toyama

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama

    Recruiting

Other trials in Japan

Australia4 sites, 4 recruiting

  • Research Site

    Brisbane

    Not yet recruiting

  • Research Site

    Melbourne

    Not yet recruiting

  • Research Site

    Perth

    Not yet recruiting

  • Research Site

    Sydney

    Not yet recruiting

Other trials in Australia

South Korea4 sites, 4 recruiting

  • Research Site

    Busan

    Not yet recruiting

  • Research Site

    Hwasun

    Not yet recruiting

  • Research Site

    Seongnam

    Not yet recruiting

  • Research Site

    Seoul

    Not yet recruiting

Other trials in South Korea

Thailand2 sites, 2 recruiting

  • Research Site

    Bangkok

    Not yet recruiting

  • Research Site

    Chiang Mai

    Not yet recruiting

Other trials in Thailand

About this study

Official title: A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer

Being tested
Futibatinib, Zimberelimab, Durvalumab, Pembrolizumab, Gemcitabine
Keywords
Futibatinib, Biliary Tract Cancer (BTC), TAS-120, Zimberelimab, AB122, Gemcitabine, Cisplatin, Durvalumab, Pembrolizumab, Phase 3, Fibroblast Growth Factor Receptor (FGFR), Programmed Cell Death Protein 1 (PD-1)
Medical subject headings
Biliary Tract Neoplasms, Acrocephalosyndactylia, Parkinson Disease 4, Autosomal Dominant Lewy Body

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 20 mg will be administered orally once daily.

  • ZimberelimabDrug

    Also called AB122

    Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.

  • DurvalumabDrug

    Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.

  • PembrolizumabDrug

    Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.

  • GemcitabineDrug

    Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

  • CisplatinDrug

    Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

Study groups in NCT07710885
Study groupRoleWhat they receive
Treatment ArmExperimentalFutibatinib + Zimberelimab + Gemcitabine + Cisplatin
Receives: Drug: Futibatinib; Drug: Zimberelimab; Drug: Gemcitabine; Drug: Cisplatin
Control ArmActive comparatorInvestigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin
Receives: Drug: Durvalumab; Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Overall Survival (OS)

    • To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC whose primary tumor site is intrahepatic or extrahepatic cholangiocarcinoma
    • To compare OS of patients in Arm A versus Arm B for patients with first-line advanced BTC

    Measured: Up to approximately 45 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment

    Measured: Up to approximately 45 months

  2. 6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments

    Measured: Up to approximately 45 months

  3. Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments

    Measured: Up to approximately 45 months

  4. Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments

    Measured: Up to approximately 45 months

  5. Adverse events (AEs)

    Measured: Up to approximately 45 months

Timeline

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

  1. First posted17 Jul 2026
  2. Study start24 Jun 2026
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion31 Dec 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
784 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07710885
Sponsor's protocol ID
10059040
Other IDs
jRCT2071260018
Acronym
FOENIX-BTC
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Futibatinib, Zimberelimab and Durvalumab in people with Biliary Tract Cancer, run by Taiho Pharmaceutical Co., Ltd. at 21 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 6 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Japan, Australia, South Korea, Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Kotaro Suto (+81-3-3294-4527, th-FOENIX-BTC-Clin.Dev@taiho.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 45 months). 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 NCT07710885.

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 17 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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