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)

+ [6]

Therapeutic Areas

NeoplasmsOther DiseasesDigestive System Disorders+ [4]

Active Indication

FGFR positive CholangiocarcinomaBile Duct NeoplasmsTriple Negative Breast Cancer+ [13]

Inactive Indication-

Originator Organization

TransThera Sciences (Nanjing), Inc.Startup

Active Organization

TransThera Sciences (Nanjing), Inc.Startup

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (United States), Orphan Drug (European Union), Breakthrough Therapy (China)

Structure/Sequence

Molecular FormulaC20H19ClN6O

InChIKeyDQFCVOOFMXEPOC-UHFFFAOYSA-N

CAS Registry2230490-29-4

Clinical Trials associated with Tinengotinib

NCT06457919

/ RecruitingPhase 1/2IIT

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

Start Date04 Jun 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

CTIS2023-505660-11-00

/ RecruitingPhase 3

A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician’s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR) altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) - TT420C2308

Start Date25 Apr 2024

Sponsor / Collaborator

TransThera Sciences (Nanjing), Inc.Startup

NCT06221774

/ Not yet recruitingPhase 1/2IIT

An Open-Label, Multi-Cohort, Two-Stage, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of TT-00420 Tablets Combined With Toripalimab Injection in Treating Advanced Urological Tumors

This Phase Ib/II clinical study is an open-label, multi-cohort, two-stage trial designed to assess the safety and efficacy of different doses of TT-00420 tablets in combination with Toripalimab injection for treating patients with advanced urological tumors. The study aims to evaluate the effectiveness of TT-00420 tablets at the optimal dose combined with Toripalimab in treating different types of advanced urological tumors.

Start Date01 Feb 2024

Sponsor / Collaborator

Nanjing Drum Tower Hospital

100 Clinical Results associated with Tinengotinib

100 Translational Medicine associated with Tinengotinib

100 Patents (Medical) associated with Tinengotinib

Literatures (Medical) associated with Tinengotinib

01 Dec 2024·Annals of Oncology

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

Article

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

BACKGROUNDFibroblast growth factor receptor (FGFR) inhibitors have significantly improved outcomes for patients with FGFR-altered cholangiocarcinoma, leading to their regulatory approval in multiple countries. However, as with many targeted therapies, acquired resistance limits their efficacy. A comprehensive, multimodal approach is crucial to characterizing resistance patterns to FGFR inhibitors.PATIENTS AND METHODSThis 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.RESULTSAmong 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 to those without clinical benefit (65% vs 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.CONCLUSIONOur 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.

01 Sep 2024·Drugs in R&D

Pharmacokinetics, Mass Balance, and Biotransformation of [14C]tinengotinib, A Novel Multi-target Kinase Inhibitor, in Healthy Subjects

Article

Author: Sun, Caixia ; Peng, Peng ; Sun, Xiaofen ; Yu, Yingying ; Ma, Sheng ; Gu, Zheming ; Yu, Zhenwen ; Miao, Liyan ; Zhang, Hua ; Wu, Frank ; Ni, Shumao ; Fan, Jean ; Wang, Hui ; Zhu, Yujia ; Li, Lin

BACKGROUND AND OBJECTIVETinengotinib, a novel multi-target small molecule kinase inhibitor, is currently undergoing phase II clinical trial in the USA and China. The purpose of this open-label study was to investigate the absorption, metabolism, and excretion of [¹⁴C]tinengotinib following a single oral dose in healthy subjects.METHODSSix healthy male subjects received a single oral dose of [¹⁴C]tinengotinib capsules at 10 mg/100 µCi, and blood, urine, and feces samples were collected. Phenotyping experiments were further conducted to confirm the enzymes involved in its metabolism.RESULTSTinengotinib was rapidly absorbed in plasma with a time to peak drug concentration (T_max) of 1.0-4.0 h post-dose and a long terminal half-life (t_½) of 23.7 h. Blood-to-plasma radioactivity concentration ratios across timepoints ranged from 0.780 to 0.827, which indicated minimal association of radioactivity with blood cells. The mean cumulative excreted radioactivity was 99.57% of the dose, including 92.46% (68.65% as unchanged) in feces and 7.11% (0.28% as unchanged) in urine. In addition to unchanged tinengotinib, a total of 11 radioactive metabolites were identified in plasma, urine, and feces. The most abundant circulating radioactivity was the parent drug in plasma, which comprised 88.23% of the total radioactivity area under the concentration-time curve (AUC). Metabolite M410-3 was a major circulating metabolite, accounting for 5.38% of the parent drug exposure and 4.75% of the total drug-related exposure, respectively. All excreted metabolites accounted for less than 5.10% and 1.82% of the dose in feces and urine, respectively. In addition, no unique metabolites were observed in humans. Tinengotinib was metabolized mainly via CYP3A4.CONCLUSIONSOverall, tinengotinib demonstrated a complete mass balance with limited renal excretion, no disproportionate blood metabolism, and slow elimination, primarily through the fecal route. The results of this study provide evidence to support the rational use of tinengotinib as a pharmacotherapeutic agent.REGISTRATIONChinadrugTrials.org.cn identifier: CTR20212852.

04 Apr 2024·The Oncologist

First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors

Article

Author: Fan, Jean ; Mott, Frank ; Raghav, Kanwal ; Hong, David S ; Fu, Siqing ; Peng, Peng ; Wu, Frank ; Ajani, Jaffer A ; Ngo, Brenda ; Ni, Shumao ; Dumbrava, Ecaterina E ; Karp, Daniel D ; Conley, Anthony P ; Xu, Binghe ; Tsimberidou, Apostolia M ; Levin, Wendy J ; Sun, Caixia ; Qiang, Xiaoyan ; Meric-Bernstam, Funda ; Ru, Qinhua Cindy ; Wang, Hui ; Javle, Milind M ; Rodon, Jordi A ; Piha-Paul, Sarina A ; Fan, Ying

AbstractPurposeThis first-in-human phase I dose-escalation study evaluated the safety, pharmacokinetics, and efficacy of tinengotinib (TT-00420), a multi-kinase inhibitor targeting fibroblast growth factor receptors 1-3 (FGFRs 1-3), Janus kinase 1/2, vascular endothelial growth factor receptors, and Aurora A/B, in patients with advanced solid tumors.Patients and MethodsPatients received tinengotinib orally daily in 28-day cycles. Dose escalation was guided by Bayesian modeling using escalation with overdose control. The primary objective was to assess dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and dose recommended for dose expansion (DRDE). Secondary objectives included pharmacokinetics and efficacy.ResultsForty-eight patients were enrolled (dose escalation, n = 40; dose expansion, n = 8). MTD was not reached; DRDE was 12 mg daily. DLTs were palmar-plantar erythrodysesthesia syndrome (8 mg, n = 1) and hypertension (15 mg, n = 2). The most common treatment-related adverse event was hypertension (50.0%). In 43 response-evaluable patients, 13 (30.2%) achieved partial response (PR; n = 7) or stable disease (SD) ≥ 24 weeks (n = 6), including 4/11 (36.4%) with FGFR2 mutations/fusions and cholangiocarcinoma (PR n = 3; SD ≥ 24 weeks n = 1), 3/3 (100.0%) with hormone receptor (HR)-positive/HER2-negative breast cancer (PR n = 2; SD ≥ 24 weeks n = 1), 2/5 (40.0%) with triple-negative breast cancer (TNBC; PR n = 1; SD ≥ 24 weeks n = 1), and 1/1 (100.0%) with castrate-resistant prostate cancer (CRPC; PR). Four of 12 patients (33.3%; HR-positive/HER2-negative breast cancer, TNBC, prostate cancer, and cholangiocarcinoma) treated at DRDE had PRs. Tinengotinib’s half-life was 28-34 hours.ConclusionsTinengotinib was well tolerated with favorable pharmacokinetic characteristics. Preliminary findings indicated potential clinical benefit in FGFR inhibitor-refractory cholangiocarcinoma, HER2-negative breast cancer (including TNBC), and CRPC. Continued evaluation of tinengotinib is warranted in phase II trials.

News (Medical) associated with Tinengotinib

09 Dec 2024

·www.prnewswire.com

2024 ESMO Asia: TransThera announces clinical data of tinengotinib in combination with atezolizumab (PD-L1) in biliary tract carcinoma (BTC)

NANJING, China and GAITHERSBURG, Md., Dec. 9, 2024 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the " TransThera") announced the poster presentation at the 2024 European Society For Medical Oncology (ESMO) Asia Congress to discuss the clinical study of tinengotinib in combination with atezolizumab (Tecentriq®) in biliary tract carcinoma (BTC). Title: Tinengotinib (TT-00420) in Combination with Atezolizumab in Chinese Patients with Biliary Tract Carcinoma (BTC): Efficacy and Safety Results from a Phase Ib/II Study Poster number: 140P Immune-checkpoint inhibitor (ICI) combined with chemotherapy have been approved as first-line therapy for BTC. However, no standard of care has been established after first-line treatment and the survival of the patients is short, there is a huge unmet clinical need. Tinengotinib is a novel multi-kinase inhibitor. It may play a role of synergistic effect when combined with ICI. The efficacy and safety data of tinengotinib in combination with atezolizumab in Chinese BTC patients has been explored in a phase Ib/II study. Results: As of September 26, 2024, a total of 31 heavily pretreated advanced BTC patients were enrolled and treated with tinengotinib plus atezolizumab. 71.0% were priorly treated with at least one immunotherapy. Promising efficacy: A total of 20 intrahepatic cholangiocarcinoma patients were efficacy evaluable. The objective response rate (ORR) and disease control rate (DCR) were 25.0% and 80.0%, the median progression free survival (mPFS) reached 8.77 months and the 12-month overall survival (OS) rate was 70.1%. A total of 28 cholangiocarcinoma patients were efficacy evaluable. The ORR and DCR were 25.0% and 75.0%, the mPFS reached 5.72 months and the 12-month OS rate was 64.8%. All 31 BTC patients were efficacy evaluable. The ORR and DCR were 22.6% and 74.2%, the mPFS reached 4.11 months and the 12-month OS rate was 61.8%. Similar efficacy was observed regardless of prior ICI(s) therapy. Good safety and tolerability: No DLT was observed in the dose escalation phase. The combination therapy was generally well tolerated in heavily pre-treated BTC patients. These encouraging results suggest the combination therapy may have synergistic effect in treating some solid tumor such as BTC, and support the further exploration to evaluate the safety and efficacy of tinengotinib plus ICI in BTC patients who were previously treated with or without ICI therapy. About Tinengotinib Tinengotinib is an internally discovered, global phase III 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 NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by 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 Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultOrphan DrugFast TrackPhase 3Immunotherapy

12 Apr 2024

·www.prnewswire.com

【2024 AACR Late Breaking Research】TransThera announces clinical data of tinengotinib to treat patients with advanced solid tumors harboring actionable FGFR1-3 alterations

NANJING, China and GAITHURSBURG, Md., April 12, 2024 /PRNewswire/ -- TransThera Sciences, a clinical-stage biopharmaceutical company focused on inventing differentiated drugs for global patients, announced the poster presentation at the 2024 American Association for Cancer Research (AACR) to discuss the latest breaking research of tinengotinib for patients with advanced solid tumors harboring actionable FGFR1-3 alterations. Monotherapy for patients with advanced solid tumors harboring actionable FGFR1-3 mutations: Fibroblast growth factor receptor (FGFR) alterations occur across various malignancies and are potent oncogenic drivers in multiple tumor types. FGFR inhibitors have demonstrated efficacy in several cancers with FGFR alterations. However, no effective therapies are available worldwide for patients with advanced solid tumors harboring actionable FGFR1-3 mutations currently. Tinengotinib is a unique multi-kinase inhibitor that has very distinct binding mode to FGFR 1-3 proteins, rendering it highly potent to a series of FGFR mutations, including gatekeeper mutations, molecular brake mutations, cystine binding site mutations, and others. This feature has made it highly differentiated from existing FGFR inhibitors, indicating its potential to target cancer patients bearing a broad range of FGFR mutations. The retrospective analysis of the pooled results from four clinical studies of tinengotinib in advanced solid tumors harboring actionable FGFR1-3 mutations showed efficacy in multiple tumor types, including cholangiocarcinoma, breast, prostate, urothelium, colon and head and neck cancer. Our data demonstrate 33.3% BOR and 88.2% DCR, 6.90 months mPFS. The promising results validated the novel mechanism of tinengotinib and clinical applications for potentially FGFR 1-3 altered patients with solid tumors. About tinengotinib Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells proliferation, angiogenesis and immune-oncology pathways by inhibiting the cytokine signaling and angiogenesis (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 and Fast Track Designation by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera Sciences (Nanjing), Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via the internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, inflammatory, and cardiovascular diseases. For more information, please visit Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc.

Clinical ResultOrphan DrugFast TrackPhase 3Breakthrough Therapy

08 Mar 2024

·www.prnewswire.com

TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

NANJING, China and GAITHURSBURG, Md., March 8, 2024 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician's choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial is enrolling to further confirm the efficacy and safety of tinengotinib in CCA. In December 2023, first patient was dosed in the United Sates (US). "We are very delighted to have achieved the significant regulatory progresses for tinengotinib in global development at various countries and regions. These milestones are not only the recognition by global regulatory authorities of the potential clinical benefit of tinengotinib to treat CCA patients, but also a reflection of the company's international regulatory capabilities and unwavering commitment to bringing innovative therapies to global patients," said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. "Leveraging the regulatory agency's support from the EU in addition to the US and other countries and regions, we will continue to expedite the global clinical development and commercialization of tinengotinib. We are hopeful that these efforts will enable us to bring this novel drug to patients around the world as quickly as we can." About ODD in EU The term "orphan medicines" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions affecting less than 5 in 10,000 people in the EU. The EMA offers a range of incentives to encourage the development of designated orphan medicines. This Orphan Drug Designation for tinengotinib qualifies it for great regulatory supports in the subsequent clinical development and commercialization in the EU, including protocol assistance, fee reductions, and most importantly, 10 years of market exclusivity upon approval. About tinengotinib Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells proliferation, angiogenesis and immune-oncology pathways by inhibiting the cytokine signaling and angiogenesis (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 and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China. In March 2024, tinengotinib was granted the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera Sciences (Nanjing), Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via the internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, inflammatory, and cardiovascular diseases. For more information, please visit Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc.

Orphan DrugPhase 3Fast TrackClinical ResultBreakthrough Therapy

100 Deals associated with Tinengotinib

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
FGFR positive Cholangiocarcinoma	Phase 3	South Korea	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Portugal	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Netherlands	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Taiwan Province	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	France	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Belgium	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Poland	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	United States	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	Spain	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
FGFR positive Cholangiocarcinoma	Phase 3	United Kingdom	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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))	(cvwbcgulwm) = wmekmxulki hpfmnnraun (rvzeqrqlhu, 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)	(cvwbcgulwm) = caxivxcahi hpfmnnraun (rvzeqrqlhu, 9.6 - NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) Manual	Phase 1/2	Biliary Tract Neoplasms	31	Tinengotinib + Atezolizumab	(dbdsdozvmi) = izdnzcnanr kxxcruebfe (nmtnflkmsh ) View more	Positive	07 Dec 2024
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	(dbdsdozvmi) = uhsunqdjsn kxxcruebfe (nmtnflkmsh ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) Manual	Phase 1/2	Solid tumor \| \|	53	Tinengotinib 5-12mg	(oucebamclx) = llzaswzopq uqqvrrutiw (hfxuembeyq ) View more	Positive	05 Apr 2024
				Tinengotinib 5-12mg (prior FGFR inhibitor)	(oucebamclx) = tdsyfxfcgm uqqvrrutiw (hfxuembeyq ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	30	Tinengotinib	(wplkwhtxxn) = mwijbesxod fpdedejwsu (idybxgompi ) View more	-	25 Jan 2024
NCT04919642 (ASCO_GI2024) Manual	Phase 2	Metastatic Cholangiocarcinoma	48	Tinengotinib 10 mg (FGFR2 fusion/rearrangement)	(gxvjgqoesc) = xzmrcsytog wbihjnhoqz (rpkslrkccb ) View more	Positive	18 Jan 2024
				Tinengotinib 10 mg (primary progression on previous FGFR inhibitor)	(gspwcueroc) = dfqfqajevv uuclfdjfee (tvnofqimpw )
PRNewswire Manual	Phase 3	Triple Negative Breast Cancer \| Hormone receptor positive HER2 negative breast cancer \| \| \| ... View more	-	tinengotinib (HR+/HER2- BC)	(tjvbhirqos) = jqeaioufop mtoowwpkzb (pkrzrtoedk ) View more	Positive	07 Dec 2023
				tinengotinib (TNBC)	(tjvbhirqos) = csnhdxwjdz mtoowwpkzb (pkrzrtoedk ) View more
NCT05253053 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm FGFR2 alteration	33	Tinengotinib	(zetmxvdbwy) = iywijqllqr ebktvhjjkb (elvhswmkic ) View more	Positive	23 Oct 2023
				Tinengotinib (measurable target lesions)	(shlwbengyr) = dkevlnrpxn tozjparxdf (hniqidbaer ) View more
NCT04742959 \| NCT03654547 \| NCT04919642 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Bile Duct Neoplasms FGFR2	73	Tinengotinib	(gxsnxnexvv) = bccxlzoual rpeamihrux (onghpglxfd ) View more	Positive	21 Oct 2023
				Tinengotinib (FGFR2 alteration who received prior FGFR)	(gxsnxnexvv) = fzsszblepf rpeamihrux (onghpglxfd ) View more
NCT04742959 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Solid tumor	157	tinengotinib (12 mg QD)	(iwjiamwwto) = In 108 efficacy-evaluable pts of monotherapy arms were 60% slcfcgsion (ravoralvez ) View more	Positive	31 May 2023
				Nab-paclitaxel+tinengotinib
NCT03654547 (ASCO_GI2023) Manual	Phase 2	Metastatic Cholangiocarcinoma FGFR alteration \| FGFR Wild-type \| FGFR2 fusion	25	tinengotinib	(elxhydozdp) = Most frequently occurred G3/4 AEs were hypertension in 6 (24%) pts, including 5 (20%) with G3 and 1 (4%) with G4, G3 fatigue in 2 (8%) and G3 neutrophil count decreased in 2 (8%) pts dicxflzkfg (suyeccpafr ) View more	Positive	24 Jan 2023
				tinengotinib (FGFR2 fusion/rearrangement pts)

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Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation