Aurora A inhibitors(Serine/threonine-protein kinase Aurora-A inhibitors), Aurora B inhibitors(Serine/threonine-protein kinase Aurora-B inhibitors), CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists)

Therapeutic Areas

NeoplasmsOther DiseasesDigestive System Disorders+ [4]

Active Indication

Advanced Bile Duct CarcinomaCarcinoma bile duct non-resectableMetastatic Cholangiocarcinoma+ [20]

Inactive Indication

Locally Advanced Malignant Solid NeoplasmSarcoma

Originator Organization

TransThera Sciences (Nanjing), Inc.

Active Organization

TransThera Sciences (Nanjing), Inc.

WUXI APPTEC, INC

药捷安康（南京）科技股份有限公司

Inactive Organization-

License Organization

Roche Holding AG

TransThera Sciences (Nanjing), Inc.

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Fast Track (United States)

Structure/Sequence

Molecular FormulaC20H19ClN6O

InChIKeyDQFCVOOFMXEPOC-UHFFFAOYSA-N

CAS Registry2230490-29-4

Clinical Trials associated with Tinengotinib

NCT07498478

/ RecruitingPhase 2

A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are:
1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
2. What medical problems do participants have when taking the combination therapy?
Participants will:
Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A.
In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

Start Date17 Mar 2026

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

NCT07328919

/ Not yet recruitingPhase 3

A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.

Start Date01 Jan 2026

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

CTR20254045

/ CompletedPhase 1

一项在健康参与者中评价多剂量伊曲康唑或利福平或艾司奥美拉唑对单剂量TT-00420药代动力学影响的单中心、开放标签、固定序列、非随机、药物相互作用的I期临床研究

[Translation] A single-center, open-label, fixed-sequence, non-randomized, drug-drug interaction phase I study evaluating the effects of multiple doses of itraconazole, rifampicin, or esomeprazole on the pharmacokinetics of a single dose of TT-00420 in healthy participants

主要目的：评价多剂量伊曲康唑或利福平或艾司奥美拉唑在健康参与者中对单剂量TT-00420药代动力学（PK）的影响次要目的：评价TT-00420与伊曲康唑或利福平或艾司奥美拉唑在健康参与者中联合给药时的安全性和耐受性

[Translation]

Primary objective: To evaluate the effects of multiple doses of itraconazole, rifampicin, or esomeprazole on the pharmacokinetics (PK) of a single dose of TT-00420 in healthy participants. Secondary objective: To evaluate the safety and tolerability of TT-00420 when co-administered with itraconazole, rifampicin, or esomeprazole in healthy participants.

Start Date03 Nov 2025

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.

100 Clinical Results associated with Tinengotinib

100 Translational Medicine associated with Tinengotinib

100 Patents (Medical) associated with Tinengotinib

Literatures (Medical) associated with Tinengotinib

01 Feb 2026·The Lancet Gastroenterology & Hepatology

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial

Article

Author: Sahai, Vaibhav ; Richards, Donald ; Peng, Peng ; Cohn, Allen ; Javle, Milind ; Ni, Shumao ; Sun, Caixia ; Fountzilas, Christos ; Pelster, Meredith ; Fonkoua, Lionel Kankeu ; Wang, Hui ; Li, Daneng ; Kingsley, Edwin ; Fan, Jean ; Liao, Chih-Yi ; Deming, Dustin ; Mahipal, Amit ; Hennessy, Katie ; Wu, Frank ; Mantry, Parvez

BACKGROUND:

Cholangiocarcinoma is a rare, aggressive cancer often driven by FGFR2 fusions, which are targetable with inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this study, we aimed to evaluate the efficacy and safety of tinengotinib in previously treated patients with advanced cholangiocarcinoma.

METHODS:

This open-label, multicentre, phase 2 trial was done at 32 medical centres in the USA. Eligible patients were aged 18 years or older with advanced or metastatic cholangiocarcinoma, who had previous systemic chemotherapy, and an Eastern Cooperative Oncology Group score of 0-1. Patients were assigned to one of four cohorts on the basis of FGFR status: cohort A1, FGFR2 fusions with primary FGFR inhibitor resistance; cohort A2, FGFR2 fusions with acquired FGFR inhibitor resistance; cohort B, other FGFR alterations; or cohort C, FGFR wild-type. Patints orally self-administered tinengotinib 10 mg daily in 28-day cycles in 28-day treatment cycles until documented disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate as per investigator assessment, defined as the proportion of patients with confirmed tumour response (complete response or partial response) that was redocumented 4 weeks or after initial assessment based on RECIST (version 1.1), as assessed by the investigator. The primary endpoint was assessed in the in the efficacy evaluable population, which included all patients who received at least one dose of tinengotinib, had measurable disease at baseline, and had at least one post-baseline tumour assessment. Safety assessed in all patients who received at least one dose of tinengotinib. This trial is registered with ClinicalTrials.gov, NCT04919642, and enrolment is complete.

FINDINGS:

Between Nov 19, 2021, and March 5, 2024, 55 patients were enrolled and assigned to one of four cohorts (cohort A1 [n=18], cohort A2 [n=11], cohort B [n=13], and cohort C [n=13]); all received tinengotinib. Patients had a median age of 61 years (IQR 56-68); 31 (56%) patients were female. All patients had received at least one previous systemic therapy. Median follow-up was 11·3 months (IQR 6·5-17·3). Among 51 patients included in the efficacy evaluable set, the objective response rate was 6·3% (95% CI 0·2-30·2; one confirmed partial response) in cohort A1, 30·0% (6·7-65·3; three confirmed partial responses) in cohort A2, 23·1% (5·0-53·8; three confirmed partial responses) in cohort B, and 0% in cohort C. Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. Grade 4 treatment-related adverse events occurred in two (4%) of 55 patients (increased lipase [n=1] and posterior reversible encephalopathy syndrome [n=1]); no grade 5 treatment-related adverse events were reported.

INTERPRETATION:

These findings suggest that tinengotinib might have activity in patients with cholangiocarcinoma with FGFR2 fusions that progressed following FGFR inhibitor therapy. Anti-tumour activity was also observed in patients with other FGFR alterations. The data from this phase 2 study supported the initiation of a phase 3 registration trial.

FUNDING:

TransThera Sciences.

01 Apr 2025·CANCER SCIENCE

Multiple Kinase Small Molecule Inhibitor Tinengotinib (TT‐00420) Alone or With Chemotherapy Inhibit the Growth of SCLC

Article

Author: Tang, Chenchen ; Zhao, Peiyan ; Qiang, Xiaoyan ; Li, Hui ; Cheng, Ying ; Li, Rixin ; Lan, Shaowei ; Peng, Peng ; Lu, Yuanhua ; Wu, Chunjiao ; Zhong, Rui ; Liu, Ying ; Wu, Frank ; Liu, Yan

ABSTRACT:

There is an urgent need to develop new targeted treatment agents for small cell lung cancer (SCLC). Tinengotinib (TT‐00420) is a novel, multi‐targeted, and spectrally selective small‐molecule kinase inhibitor that has shown significant inhibitory effects on certain solid tumors in preclinical studies. However, its role and mechanism of action in SCLC remain unclear. In this study, we demonstrated that tinengotinib effectively inhibited SCLC cell proliferation, especially highly expressing NeuroD1 (SCLC‐N), in the SCLC cell line‐derived xenograft (CDX) model and the malignant pleural effusion cell model of patients with SCLC. When combined with etoposide/cisplatin, it synergistically inhibited SCLC growth. Tinengotinib regulates proliferation, apoptosis, migration, cell cycle and angiogenesis in SCLC cells. Mechanistic studies revealed that c‐Myc expression may be a key factor influencing the effect of tinengotinib in SCLC‐N. This study provides reliable preclinical data and a new direction for tinengotinib as a promising therapy for SCLC, either alone or in combination with chemotherapy.

01 Apr 2025·ANNALS OF ONCOLOGY

A model for decoding resistance in precision oncology: acquired resistance to FGFR inhibitors in cholangiocarcinoma

Article

Author: Qiang, X ; Borad, M ; Kambadakone, A R ; Danysh, B P ; Shroff, R T ; Flaherty, K T ; Leshchiner, I ; Martin, E E ; DiToro, D ; Lennerz, J K ; Saha, S K ; Lin, B ; Javle, M ; Chen, C T ; Iyer, R ; Sun, C ; Friboulet, L ; Harris, T ; Wang, H ; Reyes, S ; Li, L ; Cleary, J M ; Stone, J R ; Fan, J ; Gordan, J D ; Karasic, T ; Bensen, D C ; Iyer, S ; Kelley, R K ; Hoffman, I D ; Berchuck, J E ; Maurer, J ; Sootome, H ; Damjanov, N ; Baiev, I ; Goyal, L ; Peng, P ; Uboha, N V ; Wehrenberg-Klee, E ; Mody, K ; Parida, L ; Getz, G ; Walmsley, C ; Hollebecque, A ; Juric, D ; Nelson, K J ; Harris, W ; Majeed, U ; Zhang, K ; Zhu, A X ; Wu, F ; Facchinetti, F ; Vasseur, D ; Hirai, H ; Pinto, C

BACKGROUND:

Fibroblast growth factor receptor (FGFR) inhibitors have significantly improved outcomes for patients with FGFR-altered cholangiocarcinoma, leading to their regulatory approval in multiple countries. As with many targeted therapies, however, acquired resistance limits their efficacy. A comprehensive, multimodal approach is crucial to characterizing resistance patterns to FGFR inhibitors.

PATIENTS AND METHODS:

This study integrated data from six investigative strategies: cell-free DNA, tissue biopsy, rapid autopsy, statistical genomics, in vitro and in vivo studies, and pharmacology. We characterized the diversity, clonality, frequency, and mechanisms of acquired resistance to FGFR inhibitors in patients with FGFR-altered cholangiocarcinoma. Clinical samples were analyzed longitudinally as part of routine care across 10 institutions.

RESULTS:

Among 138 patients evaluated, 77 met eligibility, yielding a total of 486 clinical samples. Patients with clinical benefit exhibited a significantly higher rate of FGFR2 kinase domain mutations compared with those without clinical benefit (65% versus 10%, P < 0.0001). We identified 26 distinct FGFR2 kinase domain mutations, with 63% of patients harboring multiple. While IC50 assessments indicated strong potency of pan-FGFR inhibitors against common resistance mutations, pharmacokinetic studies revealed that low clinically achievable drug concentrations may underly polyclonal resistance. Molecular brake and gatekeeper mutations predominated, with 94% of patients with FGFR2 mutations exhibiting one or both, whereas mutations at the cysteine residue targeted by covalent inhibitors were rare. Statistical genomics and functional studies demonstrated that mutation frequencies were driven by their combined effects on drug binding and kinase activity rather than intrinsic mutational processes.

CONCLUSION:

Our multimodal analysis led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. FGFR inhibitors should be small, high-affinity, and selective for specific FGFR family members. Tinengotinib, a novel small molecule inhibitor with these characteristics, exhibited preclinical and clinical activity against key resistance mutations. This integrated approach offers a blueprint for advancing drug resistance research across cancer types.

News (Medical) associated with Tinengotinib

19 Dec 2025

·www.prnewswire.com

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation (" CDE")of the National Medical Products Administration (" NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib tablets have been included in the List of Products for Priority Review and the List of Breakthrough Therapy Designation for this indication. Disclaimer: This article serves as a press release by TransThera to disclose the company's latest developments. It is not intended as a product promotion advertisement and does not constitute the company's investment advice. About Tinengotinib Tinengotinib is an internally discovered, NDA stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials conducted globally have revealed the potential of tinengotinib to be efficacious in various solid tumors, such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA), the Priority Review and Approval Procedure and the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China for the treatment of CCA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. For more information, please visit . SOURCE TransThera Sciences (Nanjing) Inc. 21% more press release views with Request a Demo

Orphan DrugFast TrackPriority ReviewBreakthrough TherapyNDA

05 Dec 2025

·www.prnewswire.com

TransThera Publishes Clinical Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Lancet

NANJING, China and GAITHERSBURG, Md., Dec. 4, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6). Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic alterations that are targetable by FGFR inhibitors such as pemigatinib and futibatinib. However, resistance to these agents commonly arises due to secondary FGFR2 mutations. In a multicenter, open-label Phase 2 trial (NCT04919642), patients with FGFR2 fusion-positive CCA who had either primary resistance or developed acquired resistance to prior FGFR inhibitor (FGFRi) therapy were enrolled, along with patients harboring other FGFR alterations or FGFR wiled-type tumors. Tinengotinib demonstrated clinical activity in patients with FGFR2 fusion-positive CCA with acquired FGFRi resistance, as well as in those with other FGFR-altered subtypes. Dr. Milind Javle of The University of Texas MD Anderson Cancer Center, corresponding author of the publication, stated: "We currently have two FDA-approved therapies targeting FGFR2 fusions in CCA. But resistance remains a major clinical challenge. As such, next generation FGFR inhibitors capable of overcoming resistance are urgently needed. Tinengotinib, as a multi-kinase FGFR inhibitor, is designed to inhibit both FGFR and compensatory pathways contributing to resistance. In this phase 2 study, tinengotinib demonstrated durable responses and meaningful clinical benefit. These promising results provide a strong rationale to proceed with a Phase 3 registration study". Dr. Jean Fan, Chief Medical Officer of TransThera, also commented: "We are very pleased that the clinical trial results have gained peer recognition and were published in such a prestigious journal. This study provides important insights into treatment strategies for patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory or relapsed CCA, including the comparison of tinengotinib versus physician's choice. We are committed to advancing global enrollment and delivering new treatment options for patients with metastatic cholangiocarcinoma." Disclaimer: This article serves as a press release by TransThera to disclose the company's latest developments. It is not intended as a product promotion advertisement and does not constitute the company's or investment advice. About Tinengotinib Tinengotinib is an internally discovered, registrational clinical stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by the National Medical Products Administration (NMPA) in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the European Medicines Agency (EMA). It was also approved for inclusion in the Priority Review and Approval Procedure by the NMPA for the treatment of CCA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. For more information, please visit SOURCE TransThera Sciences (Nanjing) Inc. 21% more press release views with Request a Demo

Orphan DrugFast TrackClinical ResultPhase 2Breakthrough Therapy

04 Dec 2025

·www.prnewswire.com

INCLUSION OF TINENGOTINIB TABLETS IN THE LIST OF PRODUCTS FOR PRIORITY REVIEW BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 3, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") of the PRC, with the proposed indication for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib has been granted Breakthrough Therapy Designation by the NMPA for the treatment of CCA. Disclaimer: This article serves as a press release by TransThera to disclose the company's latest developments. It is not intended as a product promotion advertisement and does not constitute the company's investment advice. About Tinengotinib Tinengotinib is an internally discovered, registrational clinical stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs/VEGFRs, Aurora kinases and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by the NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the EMA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. For more information, please visit SOURCE TransThera Sciences (Nanjing) Inc. 21% more press release views with Request a Demo

Orphan DrugPriority ReviewFast TrackBreakthrough Therapy

100 Deals associated with Tinengotinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Bile Duct Carcinoma	NDA/BLA	China	WUXI APPTEC, INC	19 Dec 2025
Advanced Bile Duct Carcinoma	NDA/BLA	China	TransThera Sciences (Nanjing), Inc.	19 Dec 2025
Carcinoma bile duct non-resectable	NDA/BLA	China	TransThera Sciences (Nanjing), Inc.	19 Dec 2025
Carcinoma bile duct non-resectable	NDA/BLA	China	WUXI APPTEC, INC	19 Dec 2025
Metastatic Cholangiocarcinoma	NDA/BLA	China	TransThera Sciences (Nanjing), Inc.	19 Dec 2025
Metastatic Cholangiocarcinoma	NDA/BLA	China	WUXI APPTEC, INC	19 Dec 2025
FGFR2 positive Intrahepatic Cholangiocarcinoma	Phase 3	China	TransThera Sciences (Nanjing), Inc.	08 Jan 2026
Unresectable Intrahepatic Cholangiocarcinoma	Phase 3	China	TransThera Sciences (Nanjing), Inc.	01 Jan 2026
FGFR positive Cholangiocarcinoma	Phase 3	United States	TransThera Sciences (Nanjing), Inc.	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Austria	TransThera Sciences (Nanjing), Inc.	20 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04919642 (Pubmed \| Lancet Gastroenterol Hepatol)	Phase 2	Metastatic Cholangiocarcinoma	55	Tinengotinib (FGFR2 fusions with acquired FGFR inhibitor resistance)	ymveqatwwe(iyemijfhpe) = Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. yvwyampppa (xugcxsqgjk ) View more	Positive	01 Dec 2025
NCT03654547 (ESMO2025)	Phase 1/2	Advanced Bile Duct Carcinoma FGFR2-altered	109	Tinengotinib	ufgwpjhoni(bgxhrqgrug) = evtzdqhjqu kaosjuyfxx (vqwepijhsk ) View more	Positive	17 Oct 2025
				Tinengotinib (FGFR2-altered)	osgjbiqcsc(kyhgapaozi) = nwqczpgggg aqvjhtizfb (pqpuoixesj, 9.43 - 19.48) View more
NEWS Manual	Not Applicable	Bile Duct Neoplasms	43	Tinengotinib	wmspynttav(ewnxvshxky) = ytdywuizqd fwvtunenhe (mkpfsglfpi ) View more	Positive	13 Jul 2025
NCT04919642 (TransThera's phase 2, ASCO2025)	Phase 2	Bile Duct Neoplasms FGFR2 fusion \| FGFR alterations \| FGFR wild type	37	Tinengotinib	adebouqnlc(kottvxetpd) = lmdvpbjcri znjshuztix (ashinooaei ) View more	Positive	30 May 2025
NCT04742959 (AACR2025)	Phase 1/2	Advanced Malignant Solid Neoplasm Aurora kinases A/B \| Janus kinases (JAK) \| receptor tyrosine kinases (FGFRs and VEGFRs)	197	Tinengotinib 4mg BID	gxyuxsilfw(riavpfhkxa) = No notable difference in AUC was observed in QD vs. BID schedules papkqyjpey (fbfnuqpapb ) View more	-	29 Apr 2025
				Tinengotinib 6mg BID
NCT04742959 (AACR2025)	Phase 1/2	Metastatic Cholangiocarcinoma FGFR fusions \| FGFR2 KD mutations	2	Tinengotinib 12mg once daily	wajoivmcxx(fwzfczqbvt) = suspected grade 3 TSH increase tajfclynav (mudhnzhztm ) View more	Positive	27 Apr 2025
				Chemotherapy
NCT04919642 (ASCO_GI2025) Manual	Phase 2	Metastatic Cholangiocarcinoma MED12 mutation \| ARID1A mutation	55	Tinengotinib 10 mg QD (A1: FGFR2 fusion(s) with primary progression on previous FGFR inhibitor (FGFRi))	udbzzfscas(uajzihlgdk) = qtjrzcxehq fcgwswdwpo (qldoxpafgy, 7.5 - 19.5)	Positive	23 Jan 2025
				Tinengotinib 10 mg QDTinengotinib 10 mg QD (A2: FGFR2 fusion(s) with progression after prior response to FGFRi)	udbzzfscas(uajzihlgdk) = ntkulzjlnz fcgwswdwpo (qldoxpafgy, 9.6 - NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) Manual	Phase 1/2	Biliary Tract Neoplasms	31	Tinengotinib + Atezolizumab	ytnvspxwtp(jjuenefcim) = xvfiuycjli ruvsjucfed (rqsgcwmwjj ) View more	Positive	07 Dec 2024
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	ytnvspxwtp(jjuenefcim) = eejlmrlsll ruvsjucfed (rqsgcwmwjj ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) Manual	Phase 1/2	Solid tumor FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	hgljpbaqfz(ctdqiukyam) = dlovsizpvu lbfpemujxj (lxdhlggetp ) View more	Positive	05 Apr 2024
				Tinengotinib 5-12mg (prior FGFR inhibitor)	hgljpbaqfz(ctdqiukyam) = aomfjqphgj lbfpemujxj (lxdhlggetp ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	30	Tinengotinib	bmuzfyhzuw(xlfnzqkyix) = taujxstdcu ixxqzyxfuc (ajfobccydy ) View more	-	25 Jan 2024

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