Futibatinib

Generic Name: Futibatinib

Brand Names: Lytgobi 20 Mg Daily Dose, Lytgobi

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₂N_₆O_₃

CAS Number: 1448169-71-8

Unique Ingredient Identifier: 4B93MGE4AL

Background: Futibatinib is an inhibitor of Fibroblast Growth Factor receptor (FGFR), which comprises a group of receptor tyrosine kinases that play a key role in cell proliferation, differentiation, migration, and survival. FGFR was investigated in oncology as a therapeutic target, as FGFR genomic aberrations and dysregulated FGFR signalling pathways are observed in som...

Indication: Futibatinib is indicated to treat adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. In Europe, it is indicated in patients whose disease has progressed after at least one prior line of systemic therapy.
...

Associated Conditions: Locally Advanced Intrahepatic Cholangiocarcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Unresectable Intrahepatic Cholangiocarcinoma

Associated Therapies: -

Clinical Trials

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

First Posted Date: 2024-07-18

Last Posted Date: 2024-10-31

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 15

Registration Number: NCT06506955

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

Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

Phase 2

Recruiting

Conditions: Bladder Urothelial Carcinoma
Muscle Invasive Bladder Carcinoma
Stage II Bladder Cancer AJCC v8
Stage IIIA Bladder Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Durvalumab
Drug: Futibatinib
Procedure: Magnetic Resonance Imaging
Procedure: Radical Cystectomy

First Posted Date: 2024-02-16

Last Posted Date: 2024-10-02

Lead Sponsor: Yuanquan Yang

Target Recruit Count: 24

Registration Number: NCT06263153

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Phase 2

Recruiting

Conditions: Esophageal Squamous Cell Cancer
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
Esophageal Adenocarcinoma

Interventions: Drug: Futibatinib
Drug: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: Levoleucovorin

First Posted Date: 2023-07-14

Last Posted Date: 2024-12-02

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 66

Registration Number: NCT05945823

Locations: 🇺🇸
University of California Los Angeles UCLA - Cancer Care - Santa Monica, Santa Monica, California, United States
🇺🇸
Rocky Mountain Cancer Centers Midtown, Denver, Colorado, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

and more 19 locations

Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications

Phase 1

Recruiting

Conditions: Liposarcoma
Non-small Cell Lung Cancer
Breast Cancer
Bladder Cancer
Non-Small Cell Lung Adenocarcinoma
Esophageal Cancer
Gastric Cancer
Non-Small Cell Squamous Lung Cancer
Head and Neck Squamous Cell Carcinoma
Ovarian Cancer

Interventions: Drug: BBI-355
Drug: Erlotinib
Drug: Futibatinib

First Posted Date: 2023-04-25

Last Posted Date: 2024-12-20

Lead Sponsor: Boundless Bio

Target Recruit Count: 150

Registration Number: NCT05827614

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸
Sarcoma Oncology, Santa Monica, California, United States

and more 12 locations

Personalized Medicine for Advanced Biliary Cancer Patients

Phase 3

Recruiting

Conditions: Biliary Tract Neoplasms

Interventions: Drug: Futibatinib
Drug: Cisplatin
Drug: Ivosidenib
Drug: Gemcitabine
Drug: Zanidatamab
Drug: Trastuzumab
Drug: Neratinib
Drug: Encorafenib
Drug: Binimetinib
Drug: Niraparib

First Posted Date: 2022-11-14

Last Posted Date: 2024-11-26

Lead Sponsor: UNICANCER

Target Recruit Count: 800

Registration Number: NCT05615818

Locations: 🇧🇪
Universitair Ziekenhuis Leuven, Leuven, Belgium
🇫🇷
CHU Amiens Picardie, Amiens, France
🇫🇷
CHU d'Angers, Angers, France

and more 69 locations

A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma

Phase 2

Recruiting

Conditions: Metastatic Cancer
Endometrium Cancer
Endometrial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Futibatinib

First Posted Date: 2021-09-08

Last Posted Date: 2024-08-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT05036681

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

Phase 2

Recruiting

Conditions: Advanced Hepatocellular Carcinoma
BCLC Stage A Hepatocellular Carcinoma
BCLC Stage B Hepatocellular Carcinoma
BCLC Stage C Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma

Interventions: Drug: Futibatinib
Biological: Pembrolizumab
Other: Quality-of-Life Assessment

First Posted Date: 2021-04-02

Last Posted Date: 2024-03-29

Lead Sponsor: Mayo Clinic

Target Recruit Count: 25

Registration Number: NCT04828486

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Futibatinib in Patients With Specific FGFR Aberrations

Phase 2

Active, not recruiting

Conditions: Advanced or Metastatic Gastric or Gastroesophageal Cancer
Advanced or Metastatic Solid Tumor
Myeloid or Lymphoid Neoplasms (MLN)

Interventions: Drug: Futibatinib

First Posted Date: 2019-12-06

Last Posted Date: 2024-12-04

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 115

Registration Number: NCT04189445

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba-Ken, Japan
🇺🇸
Mercy Clinic Oncology and Hematology - Coletta, Oklahoma City, Oklahoma, United States
🇮🇹
Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy

and more 58 locations

A Study of TAS-120 in Patients With Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer
FGFR 1 High Amplification
FGFR2 Amplification

Interventions: Drug: Futibatinib
Drug: Futibatinib plus Fulvestrant

First Posted Date: 2019-07-18

Last Posted Date: 2024-12-06

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 168

Registration Number: NCT04024436

Locations: 🇺🇸
BIDMC, Boston, Massachusetts, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States
🇺🇸
USCF, San Francisco, California, United States

and more 30 locations

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Phase 2

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: Atezolizumab
Drug: Amivantamab
Drug: Futibatinib

First Posted Date: 2018-12-06

Last Posted Date: 2024-04-25

Lead Sponsor: Vall d'Hebron Institute of Oncology

Target Recruit Count: 1000

Registration Number: NCT03767075

Locations: 🇮🇹
Instituto Nazionale dei Tumori di Milano, Milano, Italy
🇬🇧
Cancer Research UK Cambridge Centre, Cambridge, United Kingdom
🇩🇪
Deutsches Krebsforschungszentrum (NCT/DKFZ), Heidelberg, Baden-Wurtemberg, Germany

and more 5 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy