Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

Phase 2

• Conditions: Advanced/Metastatic Cancer
• Interventions: Drug: futibatinib, fulvestrant; Drug: futibatinib

• Registration Number: NCT06506955
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.

Detailed Description

TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.

Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-18
• Study Start: 2024-10-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Provide written informed consent.
• Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
• Ability to take medications orally (PO) (feeding tube is not permitted).

Exclusion Criteria

• Has met any discontinuation criteria within the antecedent futibatinib study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS-120 (futibatinib) combination therapy with fulvestrant	futibatinib, fulvestrant	TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design
TAS-120 (futibatinib) monotherapy	futibatinib	TAS-120 tablets, oral, cycle length is defined as per antecedent study design

Primary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.	through study completion, an average of 5 years	To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk

Trial Locations

Locations (9)

Institut De Cancerologie Strasbourg; 🇫🇷 Strasbourg, France

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Universitari, Vall d'Hebron; 🇪🇸 Barcelona, Spain

Centro Integral Oncologico; 🇪🇸 Madrid, Spain

Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom

Sarah Cannon Research Institute UK; 🇬🇧 London, United Kingdom

University College London Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom