New targeted drug shows promise for rare bile duct cancer

NCT ID NCT05727176

Recruiting now Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This Phase 2 trial is testing two doses (20 mg and 16 mg) of the oral drug futibatinib in 120 people with advanced bile duct cancer that has specific FGFR2 gene changes. Participants must have already tried standard chemotherapy. The study aims to see which dose works better at shrinking tumors and controlling the disease, while also checking safety. It is currently recruiting at multiple sites worldwide.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Futibatinib (TAS-120), an oral targeted therapy
What this could lead to: If successful, this could confirm a new standard dose for futibatinib and offer a treatment option for people with advanced bile duct cancer that has FGFR2 gene changes.
What could go wrong: This is a Phase 2 trial with only 120 participants, so results are still early. The drug may not work for everyone, and side effects like high phosphate levels or eye issues are possible.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED CHOLANGIOCARCINOMA FGFR2 FUSIONS GENE REARRANGEMENT

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

AOUI Verona - Ospedale Borgo Roma
COMPLETED

Verona, 37134, Italy
Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center
COMPLETED

Melbourne, Victoria, 3004, Australia
CEMIC
COMPLETED

CABA, 1431, Argentina
CHA Bundang Medical Center
COMPLETED

Seongnam, 13532, South Korea
Center for Oncology and Blood Disorders
WITHDRAWN

Houston, Texas, 77030, United States
Centro Hospitalar Lisboa Norte CHLN EPE - Hospital de Santa Maria
WITHDRAWN

Lisbon, 1649-035, Portugal
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
WITHDRAWN

Lublin, 20-0920, Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej - Curie
COMPLETED

Warsaw, 02-034, Poland
Clinica Universidad de Navarra
COMPLETED

Pamplona, 31008, Spain
Clinica Universidad de Navarra, Medical Oncology Service (Mariano Ponz Sarvise)
COMPLETED

Madrid, 28027, Spain
Dong-A University Hospital
WITHDRAWN

Busan, 49201, South Korea
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
COMPLETED

Otwock, 05-400, Poland
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
COMPLETED

São Paulo, 01508-010, Brazil
Fundação Champalimaud
WITHDRAWN

Lisbon, 1400-038, Portugal
Gabrail Cancer Center Research
WITHDRAWN

Canton, Ohio, 44718, United States
Grand River Hospital - Grand River Regional Cancer Centre (GRRCC)
COMPLETED

Kitchener, OH, N2G 1G3, Canada
Guangdong Provincial People's Hospitall
RECRUITING

Guangzhou, Guangdong, 510080, China
Gyeongsang National University Hospital
WITHDRAWN

Jinju, 52727, South Korea
Harbin Medical University - Cancer Hospital
RECRUITING

Harbin, Heilongjiang, China
Henry Ford Health System
COMPLETED

Detroit, Michigan, 48202, United States
Hospital Britanico
COMPLETED

Buenos Aires, AEB1280, Argentina
Hospital Erasto Gaertner
COMPLETED

Curitiba, 81520-060, Brazil
Hospital General Universitario Gregorio Maranon
COMPLETED

Madrid, 28007, Spain
Hospital Universitario 12 de octubre
COMPLETED

Madrid, 28043, Spain
Hospital Universitario Fundación Jimenez Díaz
COMPLETED

Madrid, 28040, Spain
Hospital Vall d'Hebron
COMPLETED

Barcelona, 08035, Spain
Hospital de Base de Sao Jose do Rio Preto
COMPLETED

São José do Rio Preto, 15090-000, Brazil
IOP - Instituto de Oncologia do Parana
COMPLETED

Curitiba, 80530-010, Brazil
IRCCS Humanitas Research Hospital
COMPLETED

Rozzano, 20089, Italy
Inje University Haeundae Paik Hospital
COMPLETED

Busan, 48108, South Korea
Institut Català d'Oncologia de l'Hospitalet de Llobregat - Hospital Duran i Reynals
COMPLETED

Barcelona, 08908, Spain
Instituto do Cancer do Estado de Sao Paulo
COMPLETED

Cerqueira César, 01246-000, Brazil
Jiangsu Provance Hospital
RECRUITING

Nanjing, Jiangsu, 212028, China
Jilin Cancer Hospital
RECRUITING

Changchun, Jilin, 130028, China
Kyungpook National University Hospital
WITHDRAWN

Daegu, 41944, South Korea
McGill University Health Center
COMPLETED

Montreal, Quebec, H4A 3J1, Canada
Nagasaki University Hospital
WITHDRAWN

Nagasaki, 852-8501, Japan
Nagoya University Hospital
COMPLETED

Nagoya, 466-8560, Japan
National Cancer Center Hospital East
COMPLETED

Kashiwa-Shi, 277-0882, Japan
Osaka Metropolitan University Hospital
COMPLETED

Osaka-Fu, 558-8585, Japan
Policlinico S. Orsola-Malpighi
COMPLETED

Bologna, 40138, Italy
Sanatorio de la Mujer
WITHDRAWN

Rosario, S2013, Argentina
Shandong University - Shandong Cancer Hospital
RECRUITING

Jinan, Shandong, 250117, China
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
RECRUITING

Shanghai, 200123, China
Sir Run Run Shaw Hospital, Zhejiang University
RECRUITING

Hangzhou, Zhejiang, 310016, China
St John of God Subiaco Hospital
COMPLETED

Subiaco, Western Australia, 6008, Australia
St Vincent's Hospital Sydney - The Kinghorn Cancer Centre
COMPLETED

Sydney, New South Wales, 2010, Australia
Sunnybrook Health Sciences Center
WITHDRAWN

Toronto, Ohio, M4M 3N5, Canada
Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika
WITHDRAWN

Koszalin, 75-581, Poland
Tampa General Hospital Cancer Institute
WITHDRAWN

Tampa, Florida, 33606, United States
Texas Onc Methodist (Charlton)
COMPLETED

Dallas, Texas, 75237, United States
Texas Oncology
COMPLETED

Abilene, Texas, 79606-5208, United States
Texas Oncology - Northeast
COMPLETED

Denton, Texas, 76201, United States
Texas Oncology Methodist DFW
COMPLETED

Dallas, Texas, 75230, United States
The Catholic University of Korea, St. Mary's Hospital
COMPLETED

Seoul, 06591, South Korea
The Chinese University of Hong Kong Prince of Wales Hospital
COMPLETED

New Territories, 999077, Hong Kong
The Liver Institute at Methodist Dallas Medical Center
COMPLETED

Dallas, Texas, 75203, United States
The University of Hong Kong
WITHDRAWN

Hong Kong Island, 999077, Hong Kong
Tohoku University Hospital
WITHDRAWN

Sendai, Miyagi, 980-8574, Japan
Tongji University Shanghai East Hospital
RECRUITING

Shanghai, China
University of California San Diego UCSD - Moores Cancer Center
COMPLETED

La Jolla, California, 92093, United States
University of Toronto
COMPLETED

Toronto, OH, M5G 2M9, Canada
West China Hospital- Sichuan University
RECRUITING

Chengdu, Sichuan, 610041, China
Yonsei University Health System - Severance Hospital
COMPLETED

Seoul, 03722, South Korea
Zhongahan Hospital Fudan unversity
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200032, China

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