Futibatinib (TAS-120) is currently being evaluated in numerous clinical trials investigating monotherapy and combination regimens across Phase 1, Phase 2, and Phase 3 protocols for advanced malignancies, including cholangiocarcinoma, metastatic breast cancer, non-small cell lung cancer, urothelial carcinoma, and hepatocellular carcinoma. Sponsored by commercial pharmaceutical companies and academic institutions, these studies encompass various recruitment statuses ranging from not yet recruiting and actively recruiting to active not recruiting, completed, and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07745296 | NOT_YET_RECRUITING | Biliary Tract Cancer (BTC) |
UNICANCER |
2027-01-02 | PHASE3 |
| NCT02813135 | RECRUITING | Pediatric Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2016-08-03 | PHASE1; PHASE2 |
| NCT07639528 | NOT_YET_RECRUITING | Resectable Intrahepatic Cholangiocarcinoma |
Northwestern University |
2027-12-10 | PHASE2 |
| NCT07594548 | NOT_YET_RECRUITING | Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Esophageal Adenocarcinoma; Locally Advanced Gastric Adenocarcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Metastatic Esophageal Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Unresectable Esophageal Adenocarcinoma; Unresectable Gastric Adenocarcinoma; Unresectable Gastroesophageal Junction Carcinoma |
Northwestern University |
2027-09-09 | PHASE1 |
| NCT07710885 | RECRUITING | Biliary Tract Cancer |
Taiho Pharmaceutical Co., Ltd. |
2026-06-24 | PHASE3 |
| NCT06722183 | RECRUITING | Colorectal Cancer |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2025-12-16 | PHASE2 |
| NCT02693535 | RECRUITING | Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors |
American Society of Clinical Oncology |
2016-03-14 | PHASE2 |
| NCT05615818 | RECRUITING | Biliary Tract Neoplasms |
UNICANCER |
2024-07-18 | PHASE3 |
| NCT04999761 | RECRUITING | Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer |
Taiho Pharmaceutical Co., Ltd. |
2021-06-01 | PHASE1 |
| NCT06506955 | ACTIVE_NOT_RECRUITING | Advanced/Metastatic Cancer |
Taiho Oncology, Inc. |
2024-10-01 | PHASE2; PHASE3 |
| NCT06263153 | RECRUITING | Bladder Urothelial Carcinoma; Muscle Invasive Bladder Carcinoma; Stage II Bladder Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8 |
Yuanquan Yang |
2024-12-30 | PHASE2 |
| NCT05727176 | RECRUITING | Advanced Cholangiocarcinoma; FGFR2 Fusions; Gene Rearrangement |
Taiho Oncology, Inc. |
2023-07-05 | PHASE2 |
| NCT05945823 | ACTIVE_NOT_RECRUITING | Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer; Esophageal Adenocarcinoma; Esophageal Squamous Cell Cancer; Siewert Type 1 GEJ Cancer; Pancreatic Cancer |
Taiho Oncology, Inc. |
2023-07-13 | PHASE2 |
| NCT05827614 | TERMINATED | Triple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Carcinoma; High Grade Endometrial Carcinoma; Anogenital Cancer; Head and Neck (HNSCC); Cutaneous Squamous Cell Carcinoma (CSCC); Cervical Squamous Cell Carcinoma; ER+ Breast Cancer; Leiomyosarcoma (LMS); Undifferentiated Pleomorphic Sarcoma (UPS); Pancreatic Cancer Metastatic; Small Cell Lung Cancer |
Boundless Bio, Inc. |
2023-03-24 | PHASE1 |
| NCT03767075 | RECRUITING | Advanced Solid Tumor |
Vall d'Hebron Institute of Oncology |
2018-12-10 | PHASE2 |
| NCT04189445 | TERMINATED | Advanced or Metastatic Solid Tumor; Advanced or Metastatic Gastric or Gastroesophageal Cancer; Myeloid or Lymphoid Neoplasms (MLN) |
Taiho Oncology, Inc. |
2020-08-05 | PHASE2 |
| NCT05036681 | TERMINATED | Metastatic Cancer; Endometrium Cancer; Endometrial Carcinoma |
M.D. Anderson Cancer Center |
2021-09-30 | PHASE2 |
| NCT04828486 | COMPLETED | Advanced Hepatocellular Carcinoma; BCLC Stage A Hepatocellular Carcinoma; BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Metastatic Hepatocellular Carcinoma |
Mayo Clinic |
2021-08-17 | PHASE2 |
| NCT04093362 | TERMINATED | Advanced Cholangiocarcinoma; FGFR2 Gene Rearrangements |
Taiho Oncology, Inc. |
2021-01-06 | PHASE3 |
| NCT04601857 | TERMINATED | Advanced and Metastatic Urothelial Cancer |
Taiho Oncology, Inc. |
2021-01-07 | PHASE2 |
| NCT03784014 | COMPLETED | Soft Tissue Sarcoma |
Institut National de la Santé Et de la Recherche Médicale, France |
2019-10-19 | PHASE3 |
| NCT04965818 | TERMINATED | Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations; Non-Small Cell Lung Cancer; KRAS Gene Mutation |
Taiho Oncology, Inc. |
2021-09-20 | PHASE1 |
| NCT04024436 | TERMINATED | Metastatic Breast Cancer; FGFR 1 High Amplification; FGFR2 Amplification |
Taiho Oncology, Inc. |
2020-01-28 | PHASE2 |
| NCT05827614 | Recruiting | Non-small Cell Lung Cancer|Non-Small Cell Lung Adenocarcinoma|Non-Small Cell Squamous Lung Cancer|Head and Neck Squamous Cell Carcinoma|Esophageal Cancer|Gastric Cancer|Breast Cancer|Bladder Cancer|Ovarian Cancer|Endometrial Cancer|Liposarcoma |
Boundless Bio |
2023-03-24 | Phase 1 |
| NCT04965818 | Terminated | Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations|Non-Small Cell Lung Cancer|KRAS Gene Mutation |
Taiho Oncology Inc. |
2021-09-20 | Phase 1 |
| NCT05036681 | Recruiting | Metastatic Cancer|Endometrium Cancer|Endometrial Carcinoma |
M.D. Anderson Cancer Center|National Comprehensive Cancer Network |
2021-09-30 | Phase 2 |
| NCT02052778 | COMPLETED | Cholangiocarcinoma; Urothelial Cancer; Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors; Primary CNS Tumors; Breast Cancer; Gastric Cancer |
Taiho Oncology, Inc. |
2014-07-21 | PHASE1; PHASE2 |
| NCT04024436 | Active not recruiting | Metastatic Breast Cancer|FGFR 1 High Amplification|FGFR2 Amplification |
Taiho Oncology Inc. |
2019-08-30 | Phase 2 |
| NCT02052778 | Completed | Cholangiocarcinoma|Urothelial Cancer|Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors|Primary CNS Tumors|Breast Cancer|Gastric Cancer |
Taiho Oncology Inc. |
2014-07-21 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-08-04)
Check the
Futibatinib (TAS-120)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Futibatinib (TAS-120) Solubility in DMSO
- Futibatinib (TAS-120) Stock Solution
- Futibatinib (TAS-120) Storage
- Futibatinib (TAS-120) Stability
- Futibatinib (TAS-120) Molecular Weight
- Futibatinib (TAS-120) SMILES
- Futibatinib (TAS-120) CAS Number
- Futibatinib (TAS-120) Chemical Structure (2D and 3D)
- Futibatinib (TAS-120) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.