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

13. juli 2026 opdateret af: Taiho Pharmaceutical Co., Ltd.

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

784

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • Brisbane, Australien
        • Ikke rekrutterer endnu
        • Research Site
      • Melbourne, Australien
        • Ikke rekrutterer endnu
        • Research Site
      • Perth, Australien
        • Ikke rekrutterer endnu
        • Research Site
      • Sydney, Australien
        • Ikke rekrutterer endnu
        • Research Site
  • Japan
      • Aichi, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Fukuoka, Japan
        • Rekruttering
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Hokkaido, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Kanagawa, Japan
        • Ikke rekrutterer endnu
        • Kanagawa Cancer Center
      • Miyagi, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Osaka, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Tokyo, Japan
        • Ikke rekrutterer endnu
        • Research Site
      • Tokyo, Japan
        • Rekruttering
        • The Cancer Institute Hospital
      • Toyama, Japan
        • Rekruttering
        • Toyama University Hopspital
      • Wakayama, Japan
        • Rekruttering
        • Wakayama Medical University Hospital
  • Sydkorea
      • Busan, Sydkorea
        • Ikke rekrutterer endnu
        • Research Site
      • Hwasun, Sydkorea
        • Ikke rekrutterer endnu
        • Research Site
      • Seongnam, Sydkorea
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea
        • Ikke rekrutterer endnu
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Ikke rekrutterer endnu
        • Research Site
      • Chiang Mai, Thailand
        • Ikke rekrutterer endnu
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. 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;

  2. 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.
  3. Has radiographically measurable disease per RECIST v1.1.
  4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
  5. 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.

Exclusion Criteria:

  1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
  2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
  3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
  4. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Arm
Futibatinib + Zimberelimab + Gemcitabine + Cisplatin
Medicin: Futibatinib
Futibatinib 20 mg will be administered orally once daily.
Andre navne:
  • TAS-120
Medicin: Zimberelimab
Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.
Andre navne:
  • AB122
Medicin: Gemcitabine
Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Medicin: Cisplatin
Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Aktiv komparator: Control Arm
Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin
Medicin: Gemcitabine
Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Medicin: Cisplatin
Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
Medicin: Durvalumab
Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.
Medicin: Pembrolizumab
Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Up to approximately 45 months
  • 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
Up to approximately 45 months

Sekundære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Up to approximately 45 months
Up to approximately 45 months
6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments
Tidsramme: Up to approximately 45 months
Up to approximately 45 months
Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments
Tidsramme: Up to approximately 45 months
Up to approximately 45 months
Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments
Tidsramme: Up to approximately 45 months
Up to approximately 45 months
Adverse events (AEs)
Tidsramme: Up to approximately 45 months
Up to approximately 45 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Samarbejdspartnere

Taiho Oncology, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. juni 2026

Primær færdiggørelse (Anslået)

30. april 2030

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10059040
  • jRCT2071260018 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Galdevejskræft

Kliniske forsøg med Futibatinib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in India

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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