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

Recruiting now · Phase 2

Conditions studied: Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement

In brief

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.

Key facts

Study ID

NCT05727176

Run by

Taiho Oncology, Inc.

People needed

120

Starts

2023-07-05

Expected to finish

2026-12-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.

Where it is running

• Jilin Cancer Hospital — Changchun, Jilin, China (enrolling)
• Shanghai Gobroad Cancer Hospital China Pharmaceutical University — Shanghai, China (enrolling)
• Sir Run Run Shaw Hospital, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• Shandong University - Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Guangdong Provincial People's Hospitall — Guangzhou, Guangdong, China (enrolling)
• Harbin Medical University - Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Jiangsu Provance Hospital — Nanjing, Jiangsu, China (enrolling)
• West China Hospital- Sichuan University — Chengdu, Sichuan, China (enrolling)
• Tongji University Shanghai East Hospital — Shanghai, China (enrolling)
• Texas Oncology Methodist DFW — Dallas, Texas, United States
• Sanatorio de la Mujer — Rosario, Argentina
• CEMIC — CABA, Argentina
• St Vincent's Hospital Sydney - The Kinghorn Cancer Centre — Sydney, New South Wales, Australia
• Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center — Melbourne, Victoria, Australia
• The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hospital Britanico — Buenos Aires, Argentina
• Fundacao Antonio Prudente - A.C.Camargo Cancer Center — São Paulo, Brazil
• Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, Brazil
• Center for Oncology and Blood Disorders — Houston, Texas, United States
• Sunnybrook Health Sciences Center — Toronto, Ohio, Canada
• Grand River Hospital - Grand River Regional Cancer Centre (GRRCC) — Kitchener, OH, Canada
• University of Toronto — Toronto, OH, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• Texas Oncology — Abilene, Texas, United States

Full record on ClinicalTrials.gov

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