Delving into the Latest Updates on Futibatinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Futibatinib (JAN/USAN/INN), 福替巴替尼, TAS 120

+ [3]

Target

FGFR1 x FGFR2 x FGFR3 x FGFR4

Action

antagonists

Mechanism

FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersOther Diseases+ [4]

Active Indication

FGFR2 fusion or rearranged CholangiocarcinomaIntrahepatic CholangiocarcinomaBiliary Tract Neoplasms+ [18]

Inactive Indication

Advanced Malignant Solid NeoplasmAdvanced Urothelial CarcinomaBrain Cancer+ [8]

Originator Organization

Taiho Pharmaceutical Co., Ltd.

Active Organization

Taiho Oncology, Inc.

Taiho Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Sep 2022),

Intrahepatic Cholangiocarcinoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)

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Structure/Sequence

Molecular FormulaC22H22N6O3

InChIKeyKEIPNCCJPRMIAX-HNNXBMFYSA-N

CAS Registry1448169-71-8

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

Start Date10 Dec 2027

Sponsor / Collaborator

Northwestern University

[+1]

NCT07594548

/ Not yet recruitingPhase 1IIT

A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

Start Date09 Sep 2027

Sponsor / Collaborator

Northwestern University

[+1]

NCT07745296

/ Not yet recruitingPhase 3IIT

Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer

The objective of SAFIR-IMPACT BTC is to see whether, combining or replacing the standard adjuvant chemotherapy with a targeted therapy matched to the person's cancer, is better than the standard treatment alone in delaying or preventing the return of the cancer.
Three different targeted therapies will be evaluated, each of which recognises a different type of abnormality in cancer cells:
* Ivosidenib - a drug which acts on a specific abnormality in a protein called IDH1.
* Futibatinib - a drug which acts on abnormalities in a protein called FGFR2
* Zanidatamab - a drug which acts on cancers that produce more than the usual quantity of a protein called HER2.
The trial is composed of two phases:
(i) An initial screening phase to identify a suitable patient population, during which a sample of the patient's tumour will be tested to see if it has one of the target abnormalities being studied (ii) a randomised comparative phase (for selected patients only) which consists of comparing two treatment options: some patients will receive the targeted therapy specific to the abnormality identified in their tumour, while others will receive the standard treatment. Patients will be assigned to one treatment or the other by a random draw: they will have a 2 in 3 chance of receiving the targeted therapy.
Randomised participants will:
* Take their assigned treatment for 6 months
* Visit the clinic once every 3 weeks for checkups and tests
* Keep a diary of their symptoms and the treatment they take at home Follow-up information will be collected for all participants until the end of the trial.

Start Date02 Jan 2027

Sponsor / Collaborator

UNICANCER

100 Clinical Results associated with Futibatinib

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100 Translational Medicine associated with Futibatinib

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100 Patents (Medical) associated with Futibatinib

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153

Literatures (Medical) associated with Futibatinib

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Isolation, structural elucidation and cytotoxicity evaluation of novel degradation impurities of futibatinib

Article

Author: Wang, Qin ; Wu, Wenyi ; Cai, Liangliang ; Wang, Xinfeng ; Ma, Xiaofei ; Sun, Ming

Futibatinib (TAS-120) is a next-generation covalent inhibitor of fibroblast growth factor receptor (FGFR) 1-4 that has been authorized for the treatment of patients with previously treated intrahepatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements. However, information regarding its degradation behavior and impurity profile remains limited. The stability behavior of futibatinib under a series of forced degradation conditions was comprehensively evaluated using an HPLC-based analytical approach. Forced degradation studies demonstrated that futibatinib was relatively stable under oxidative, thermal, and photolytic conditions, whereas significant degradation occurred under alkaline conditions. Two previously unreported degradation-related products, designated as Fut-1 and Fut-2, were generated under intensified alkaline conditions and subsequently isolated by preparative liquid chromatography. Fut-1 and Fut-2 were characterized using high-resolution mass spectrometry, nuclear magnetic resonance and heteronuclear multiple bond correlation spectroscopy. Based on comprehensive spectral analyses, Fut-1 was identified as (S)-3-((3,5-dimethoxyphenyl)ethynyl)-1-(pyrrolidin-3-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine, while Fut-2 was identified as (S)-1-(3-(4-amino-3-((3,5-dimethoxyphenyl)ethynyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)pyrrolidin-1-yl)-3-methoxypropan-1-one. Structural analysis suggested that degradation primarily involved transformation of the acrylamide side chain, whereas the pyrazolo[3,4-d]pyrimidine core and the 3,5-dimethoxyphenyl-ethynyl moiety remained largely intact. In vitro cytotoxicity studies against five human tumor cell lines revealed that Fut-1 retained considerable cytotoxic activity and exhibited stronger inhibitory effects than futibatinib in several cell lines, whereas Fut-2 showed reduced activity. The results provide valuable insights into the structural transformation behavior, impurity profiling, and quality control considerations of futibatinib and may contribute to future investigations of structure-activity relationships of futibatinib-related compounds.

01 Oct 2026·EUROPEAN JOURNAL OF CANCER

Futibatinib after non-covalent FGFR inhibitors in FGFR2-rearranged intrahepatic cholangiocarcinoma: clinical activity and resistance patterns

Article

Author: Vogel, Arndt ; Bridgewater, John ; Messineo, Luisa ; Zecchetto, Camilla ; Sordo, Anna ; Mendo, Lucia ; Tasselli, Ester ; Casalino, Simona ; Gerdes, Christoph ; Cruz, Marina Crespo ; Saborowski, Anna ; Melisi, Davide ; Quinzii, Alberto ; Scarlato, Enza

PURPOSE:

The optimal sequencing of non-covalent and covalent FGFR inhibitors in FGFR2-rearranged intrahepatic cholangiocarcinoma (iCCA) remains undefined. Futibatinib, an irreversible FGFR1-4 inhibitor, may retain activity in the setting of acquired resistance to non-covalent FGFR inhibitors, but data on the patterns of acquired alterations are limited.

METHODS:

We conducted a retrospective multicenter study across three European centers including patients with advanced FGFR2-rearranged iCCA treated with futibatinib after progression on non-covalent FGFR inhibitors. Clinical outcomes and safety were evaluated. Available genomic profiling at progression was analyzed to characterize resistance mechanisms and their association with outcomes.

RESULTS:

Sixteen patients were included. Median progression-free survival (mPFS) with prior non-covalent FGFR inhibitors was 10.2 months (95% CI 7.0-15.5), with an objective response rate (ORR) of 60.0%. Among patients with post-progression genomic profiling (n = 11), all harbored FGFR2 resistance mutations, with polyclonal alterations (≥2) in 45.5%. A higher burden of FGFR2 mutations and the presence of co-alterations were associated with shorter mPFS on non-covalent inhibitors. Futibatinib was administered at a median of fourth-line therapy. ORR was 31.3% and disease control rate was 50.0%. Median PFS and overall survival were 4.5 months (95% CI 2.0-9.1) and 9.9 months (95% CI 5.7-not reached), respectively. Notably, outcomes with futibatinib were independent of the number of acquired FGFR2 resistance mutations, and the adverse impact of co-alterations appeared attenuated. Safety was consistent with the known profile.

CONCLUSIONS:

Futibatinib demonstrates clinically meaningful activity after progression on non-covalent FGFR inhibitors, supporting its use in FGFR2-rearranged iCCA, including in the post-non-covalent inhibitor setting. The distinct resistance patterns provide a biological rationale for the continued efficacy of covalent FGFR inhibition. Prospective studies incorporating longitudinal molecular profiling are needed to optimize treatment sequencing.

01 Oct 2026·JOURNAL OF HEPATOLOGY

Systemic therapy of biliary tract cancer: The road to personalised strategies

Review

Author: Harding, James J ; Lamarca, Angela ; Oh, Do Youn

Biliary tract cancers (BTC), including cholangiocarcinoma, gallbladder cancer, and ampullary cancer, remain poor-prognosis tumours. Chemo-immunotherapy is now established as the first-line standard of care. In parallel, precision medicine is now well established in the form of targeted therapies. These have transformed outcomes for defined subgroups, particularly intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements, where pemigatinib and futibatinib provide meaningful response rates and durable disease control. On top of this, next-generation FGFR inhibitors aim to address secondary resistance. IDH1-mutant cholangiocarcinoma benefits from ivosidenib, with multiple combination strategies currently under investigation. HER2-directed therapies, including zanidatamab and trastuzumab deruxtecan, have shown promising efficacy in HER2-amplified or strongly overexpressing BTC, with ongoing clinical trials in the first-line setting. Tumour-agnostic targets (BRAF V600E, MSI-H/dMMR, RET/NTRK/NRG1 fusions) and other emerging therapies are further broadening therapeutic opportunities. However, key barriers to implementation include heterogeneous biomarker testing, limited tissue availability, the need for DNA/RNA hybrid-capture sequencing, and evolving resistance biology, underscoring the importance of optimised diagnostics and innovative trial designs to realise personalised care in BTC. This review provides detailed insights on these therapies, and most importantly a view to what the future may hold.

45

News (Medical) associated with Futibatinib

24 Sep 2026

·www.fiercepharma.com

Elevar wins FDA nod for bile duct cancer drug Lyrfigtu, a first for a Korean firm

The FDA came to Elevar Therapeutics bearing gift ahead of the mid-autumn festival. The U.S. agency has approved the company’s Lyrfigtu (lirafugratinib) for patients with previously treated bile duct cancer harboring an FGFR2 gene fusion or other rearrangement. As Jin Yang-gon, chairman of HLB Group, Elevar’s parent company, noted in a YouTube announcement , Lyrfigtu marks the first novel cancer drug from a Korean company to secure FDA approval. “The greatest gift brought by this new drug approval is the newfound confidence spreading throughout the company, bolstered by the achievement of becoming a firm with a global anti-cancer drug,” Jin said during the auto English-dubbed announcement. “Our goal was to complete new drug development independently, rather than relying on technology exports, which require waiting for others to develop and produce results.” Compared with existing FGFR inhibitors such as Incyte’s Pemazyre and Taiho’s Lytgobi , Lyrfigtu was designed with increased selectivity for FGFR2, while sparing other proteins of the FGFR family, to minimize toxicities. Elevar obtained the asset from Relay Therapeutics in 2024 for $75 million in upfront and regulatory milestone payments and up to $425 million in potential commercial milestones. In a single-arm trial called Refocus, Lyrfigtu registered an objective response rate of 46% and a median duration of response reaching 11.8 months among 116 patients with cholangiocarcinoma new to FGFR inhibitor treatment but who had received prior chemotherapy or chemoimmunotherapy. The median progression-free survival was 11.3 months. “Lyrfigtu’s unique, irreversible, covalent-binding mechanism enables potent and sustained inhibition of FGFR2, including many resistance mutations that can emerge with earlier FGFR inhibitors,” Lipika Goyal, M.D., from the Stanford Cancer Center and lead author of the Refocus trial, said in a Sept. 23 announcement. “This FDA approval brings an important next-generation precision medicine option directly to patients with advanced bile duct cancer.” Elevar expects to make Lyrfigtu to patients in the U.S. this year. The company also filed an application with the European Medicines Agency on Sept. 15, Jin said. Jin touted Lyrfigtu’s potential in other cancer types, including ongoing clinical trials in a tumor-agnostic setting, as well as opportunities to be combined with other anticancer drugs by Big Pharma. Now that the drug has been approved, the company expects patient enrollment in clinical trials to accelerate, Jin said. The milestone of an FDA approval came years late for Elevar and its parent HLB. The company’s first U.S. approval was supposed to be the combination of camrelizumab and rivoceranib, partnered with China’s Hengrui Pharma, for the first-line treatment of liver cancer. However, beginning with a pair of complete response letters in May 2024, the two drugs have been rejected three times, all because of manufacturing shortfalls at Hengrui’s facilities. Following the most recent snub in July, Hengrui has solved the issues, and the partners are now gathering updated safety data for a resubmission, according to Jin.

13 Aug 2026

·www.fiercebiotech.com

Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal

Taiho Pharmaceutical and Cullinan Therapeutics have scored a second phase 3 victory for their small molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung cancer niche. The study evaluated the combination of zipalertinib and platinum-based chemotherapy in the first-line treatment of adults with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Investigators randomized 285 patients to receive the combination or chemotherapy alone. Progression-free survival (PFS) was significantly longer on the combination than on chemotherapy alone, hitting the study’s primary efficacy endpoint at a planned interim analysis. The partners have yet to share the PFS data but called the improvement “clinically meaningful.” Based on the data, which the partners said showed a “manageable” safety profile, the independent data monitoring committee recommended unblinding the study. Investigators will continue to monitor safety and efficacy. Taiho and Cullinan plan to seek approval for the zipalertinib-chemotherapy combination in the first-line setting. In April, the FDA accepted zipalertinib for review in NSCLC patients with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The FDA is set to approve or reject zipalertinib in that setting by Feb. 27 next year. Under the terms of its 2022 deal with Taiho, Cullinan is in line to receive $30 million when zipalertinib is approved for second-line use and $100 million when it secures a first-line nod from the FDA. Taiho and Cullinan will split pretax profits from U.S. sales equally. Responsibility for driving those sales will fall on Taiho, which already markets three cancer drugs—Inqovi, Lonsurf and Lytgobi—that won FDA approval this decade. Zipalertinib will enter an NSCLC niche already served by Johnson & Johnson’s Rybrevant, a bispecific that received FDA approval for second-line use in 2021 and a first-line nod in 2024. Sales of Rybrevant and Lazcluze, a drug used in combination with the bispecific in some settings, grew (PDF) 70% to $546 million in the first half of 2026. J&J has grown sales amid a lack of competition for the EGFR exon 20 NSCLC market. Takeda withdrew its challenger, Exkivity, in 2023 over a failed trial, leaving J&J without a rival until the FDA approved Dizal Pharmaceutical’s Zegfrovy in 2025. Competition for the market is intensifying. AstraZeneca, which created Dizal in a spinout in 2017, paid $600 million upfront for exclusive global rights to Zegfrovy last month. If zipalertinib wins FDA approval, Taiho will be locked in a three-way fight with AstraZeneca and J&J for the NSCLC niche.

25 Jun 2026

·allsci.com

HUTCHMED’s fanregratinib posts pivotal Phase II data as China NDA enters priority review

HUTCHMED’s fanregratinib demonstrated a 42.5% objective response rate in pretreated patients with FGFR2 fusion-positive intrahepatic cholangiocarcinoma, according to pivotal Phase II data presented at the ESMO Gastrointestinal Cancers Congress 2026 in Munich — findings that underpin a New Drug Application already accepted for priority review by China’s National Medical Products Administration. The registration-enabling single-arm study (NCT04353375) enrolled 235 patients with advanced ICC across 53 sites in China, all of whom had received at least one prior line of systemic therapy; all had prior chemotherapy exposure and 72% had received prior immunotherapy. The Independent Review Committee-assessed ORR of 42.5% (95% CI: 30.0%–53.6%) met the primary endpoint. Median time to response was 1.4 months, median duration of response was 6.9 months (95% CI: 5.6–8.5), and disease control rate reached 83.9% (95% CI: 74.5%–90.9%). Median PFS was 6.9 months (95% CI: 4.1–8.2) and median OS was 16.6 months (95% CI: 12.4–16.6). Grade 3 or higher drug-related adverse events were reported in 48.3% of patients, most commonly liver enzyme elevations and palmar-plantar erythrodysesthesia syndrome; treatment discontinuation due to drug-related adverse events occurred in 2.2% of patients, and no treatment-related deaths were recorded. The open-label, single-arm Phase II design — conducted exclusively in China — limits direct generalizability to broader global populations and precludes a randomized efficacy comparison. The absence of a control arm means OS and PFS findings reflect the natural history of a heavily pretreated cohort alongside drug effect, without formal separation of the two. Fanregratinib selectively inhibits FGFR1, 2, and 3, targeting aberrant FGFR2 fusion-driven signaling implicated in ICC tumor proliferation. In the approved FGFR inhibitor class, pemigatinib (Pemazyre) reported an ORR of 35.5% in second-line FGFR2 fusion-positive ICC in the FIGHT-202 study, while futibatinib (Lytgobi) reported 41.7% in the FOENIX-CCA2 trial — both in similarly pretreated populations, though cross-trial comparisons are limited by differences in study design, duration, and patient populations. HUTCHMED retains worldwide rights to fanregratinib. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 Deals associated with Futibatinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D11725	-	L01EN04	DB15149

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
FGFR2 fusion or rearranged Cholangiocarcinoma	Japan	Taiho Pharmaceutical Co., Ltd.	26 Jun 2023
Intrahepatic Cholangiocarcinoma	United States	Taiho Oncology, Inc.	30 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	NDA/BLA	Japan	Taiho Pharmaceutical Co., Ltd.	30 Jan 2022
Advanced biliary tract cancer	Phase 3	Japan	Taiho Pharmaceutical Co., Ltd.	24 Jun 2026
Advanced biliary tract cancer	Phase 3	Australia	Taiho Pharmaceutical Co., Ltd.	24 Jun 2026
Advanced biliary tract cancer	Phase 3	South Korea	Taiho Pharmaceutical Co., Ltd.	24 Jun 2026
Advanced biliary tract cancer	Phase 3	Thailand	Taiho Pharmaceutical Co., Ltd.	24 Jun 2026
Neoplasm Metastasis	Phase 3	United States	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	France	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	South Korea	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	Spain	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	United Kingdom	Taiho Oncology, Inc.	01 Oct 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Intrahepatic Cholangiocarcinoma FGFR2 fusions	16	Futibatinib	lqnmptgwwc(pwcxyrmlhh) = uvqhcqpvdt kcavpetomp (cykigooadz ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Biliary Tract Neoplasms	100	Futibatinib	rcuaewdvyu(namixwvxwz) = dnyemqnppw srklnpwxym (wpktffhwkz, 10.3 - NR) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Biliary Tract Neoplasms	100	Pemigatinib	rcuaewdvyu(namixwvxwz) = zjopqmtven srklnpwxym (wpktffhwkz, 19.2 - NR) View more	Positive	23 Oct 2026
NCT04999761 (ESMO_GI2026 \| ESMO_GCC2026)	Phase 1	Metastatic Biliary Tract Carcinoma First line	43	Zimberelimab 360 mgCisplatin 25 mg/m2Gemcitabine 1000 mg/m2Futibatinib 20 mg + Zimberelimab 360 mgCisplatin 25 mg/m2Gemcitabine 1000 mg/m2Futibatinib 20 mgmg + Zimberelimab 360 mgCisplatin 25 mg/m2Gemcitabine 1000 mg/m2Futibatinib 20 mgmg/m2 + Zimberelimab 360 mgCisplatin 25 mg/m2Gemcitabine 1000 mg/m2Futibatinib 20 mg2	jnwahzyoqp(icfvwyufov) = didwbmphbk qxjtswmlfn (jkzpqzmcba ) View more	Positive	02 Jul 2026
ASCO2026	Not Applicable	Intrahepatic Cholangiocarcinoma	237	Pemigatinib or futibatinib	inudufurvb(tyciefyyct) = llhvpuxjtc zxmjapijdt (rclqxzwqqr ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Bile Duct Neoplasms	215	Futibatinib	vhskrewogr(etzycvoldi) = qjtddysyxc adxzajunib (uazhjjrksj ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Bile Duct Neoplasms	215	Pemigatinib	vhskrewogr(etzycvoldi) = gsfxaqebix adxzajunib (uazhjjrksj ) View more	Positive	29 May 2026
NCT04965818 (Pubmed \| Invest New Drugs)	Phase 1	Advanced cancer KRAS-mutant	23	Futibatinib	lfugozezax(rrgghjmbpz) = limiting dose escalation beyond futibatinib 16 mg QD plus binimetinib 15 mg BID golioxngai (jihnwcmyfk ) View more	Positive	18 May 2026
NCT04828486 (ASCO_GI2026)	Phase 2	Metastatic hepatocellular carcinoma Second line FGF19+	14	Futibatinib 20 mg once daily + Pembrolizumab 200mg every 3 weeks (FGF19 expressing + advanced or metastatic hepatocellular carcinoma)	hbtlqoyodu(osvzhvaiuq) = zltxadpcxg jssxfdtzff (erqavzwdum, 8.6 - 62.3) View more	Negative	08 Jan 2026
NCT04601857 (CTgov)	Phase 2	Metastatic urothelial carcinoma \| Transitional Cell Carcinoma	43	Futibatinib+Pembrolizumab (Cohort A)	knmrcfvlcr = dkcbwdcrfu rprivqhwjf (gibcuqakkm, bvnqpvbamm - axzufykksd) View more	-	31 Dec 2025
NCT04601857 (CTgov)	Phase 2		43	Futibatinib+Pembrolizumab (Cohort B)	knmrcfvlcr = xxvkvkgawm rprivqhwjf (gibcuqakkm, rfibnmlhva - fehzqmuwsn) View more	-	31 Dec 2025
NCT04024436 (FOENIX-MBC2, CTgov)	Phase 2	Metastatic breast cancer	64	Futibatinib (Futibatinib (Cohort 1))	awpisqbmho = xmkxcviltb xpjsumncxr (vhyzubkuim, qlaskdvacm - hypkassouw) View more	-	13 Nov 2025
NCT04024436 (FOENIX-MBC2, CTgov)	Phase 2	Metastatic breast cancer	64	Futibatinib (Futibatinib (Cohort 2))	awpisqbmho = bucihpvqds xpjsumncxr (vhyzubkuim, mznekxtchs - wobflcgcvy) View more	-	13 Nov 2025
NCT04828486 (CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	14	Quality-of-Life Assessment+Futibatinib+Pembrolizumab	kwkdbxrdqi = rqkygldgfo dilfpsxrmu (tlpceyeubx, aysrbvygbh - wfbqozpmpx) View more	-	29 Oct 2025