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

Bile Duct NeoplasmsTriple Negative Breast CancerMetastatic castration-resistant prostate cancer+ [9]

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-

RegulationOrphan Drug (US), Breakthrough Therapy (CN), Fast Track (US), Orphan Drug (EU)

Structure

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 / Recruiting

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

BACKGROUND AND OBJECTIVE:

Tinengotinib, 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.

METHODS:

Six 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.

RESULTS:

Tinengotinib 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.

CONCLUSIONS:

Overall, 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.

REGISTRATION:

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

Abstract:

Purpose:

This 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 Methods:

Patients 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.

Results:

Forty-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.

Conclusions:

Tinengotinib 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.

01 Feb 2023·Molecular cancer therapeutics

Tinengotinib (TT-00420), a Novel Spectrum-Selective Small-Molecule Kinase Inhibitor, Is Highly Active Against Triple-Negative Breast Cancer

Article

Author: Wu, Di ; Li, Guoyu ; Qiang, Xiaoyan ; Yu, Qi ; Hu, Chao ; Peng, Peng ; Li, Lin ; Sourd, Laura ; Wu, Frank ; Wang, Dong ; Marangoni, Elisabetta ; Ni, Shumao

Abstract:

Triple-negative breast cancer (TNBC) is a highly heterogeneous cancer lacking actionable targets. Using a phenotypic screen of TNBC cells, we discovered a novel multiple kinase inhibitor tinengotinib (TT-00420) that strongly inhibited Aurora A/B, FGFR1/2/3, VEGFRs, JAK1/2, and CSF1R in biochemical assays. Exposure to tinengotinib specifically inhibited proliferation across all subtypes of TNBC in vitro and in vivo, while leaving luminal breast cancer cells intact. Incubation of HCC1806 with tinengotinib led to dose-dependent downregulation of genes essential for TNBC cell growth and proliferation. Studies revealed that the potential mechanism of action of tinengotinib involved, predominantly, inhibition of Aurora A or B kinase activity, while inhibition of other pathways contributed to suppression of potency and activity. In vitro treatment of TNBC cell lines or in vivo administration in a syngeneic model with tinengotinib resulted in up-regulation of CXCL10 and 11 or diminished tumor-associated macrophage (TAM) infiltration. Tinengotinib represents a novel combinatorial inhibitory mechanism to treat TNBC. The phase I trial of tinengotinib was completed (ClinicalTrials.gov identifier: NCT03654547).

News (Medical) associated with Tinengotinib

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

21 Dec 2023

·www.biospace.com

TransThera Announces the Global Multicenter Phase 3 Clinical Trial Completed First Patient Dosing in the US Evaluating Tinengotinib in FGFRi Relapsed/Refractory Patients with Cholangiocarcinoma

NANJING, China and GAITHURSBURG, Md., Dec. 21, 2023 /PRNewswire/ -- TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announces the first patient has been dosed in the US for the Phase 3 trial FIRST-308 of tinengotinib (TT-00420), an investigational next generation FGFR inhibitor to treat advanced FGFR-altered cholangiocarcinoma（CCA）patients who had progressed on prior systemic therapy and FGFR inhibitors. This study is a Phase 3, randomized, controlled, global multicenter study to evaluate the efficacy and safety of oral tinengotinib versus physician's choice in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma. The study is planned to be conducted in the US, the EU, the UK, Asia, and other countries and regions, and the final results will support a global marketing application for tinengotinib. "We are thrilled to have dosed the first US patient in our Phase 3 trial and appreciate the effort and participation by clinicians and patient. It is also an important indicator of TransThera's international clinical execution capabilities." said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. "We will be committed to advancing the development of tinengotinib that has potential to demonstrate clinical benefit for CCA patients with high unmet medical needs and are looking forward to the progress in FIRST-308 study to bring the novel therapy to CCA patients." About tinengotinib Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. 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. About TransThera TransThera, including TransThera Sciences (Nanjing), Inc. and TransThera Sciences (US) 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.

Fast TrackPhase 3Orphan Drug

100 Deals associated with Tinengotinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bile Duct Neoplasms	Phase 3	US	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	AT	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	BE	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	FR	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	DE	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	IT	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	NL	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	PL	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	PT	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023
Bile Duct Neoplasms	Phase 3	KR	TransThera Sciences (Nanjing), Inc.Startup	20 Dec 2023

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) Manual	Phase 1/2	Solid tumor FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	ystteqzost(uukwjvxnlh) = auncsfhhfv vkhoktqmrg (ekogpqogae ) View more	Positive	05 Apr 2024
				Tinengotinib 5-12mg (prior FGFR inhibitor)	ystteqzost(uukwjvxnlh) = ezpiycsvsa vkhoktqmrg (ekogpqogae ) View more
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) Manual	Not Applicable	Metastatic castration-resistant prostate cancer	30	Tinengotinib	wbozlziwqw(clksblzvdu) = elyjztnody recjanimsl (zhzdhohuhk ) View more	-	25 Jan 2024
NCT04919642 (ASCO_GI2024) Manual	Phase 2	Metastatic Cholangiocarcinoma FGFR Mutation	48	Tinengotinib 10 mg (FGFR2 fusion/rearrangement)	nezdhwpcui(hwfhrmslfu) = pdghqcbpwz xbucbrxjjv (acydfutdlw ) View more	Positive	18 Jan 2024
				Tinengotinib 10 mg (primary progression on previous FGFR inhibitor)	twdypokafy(crtbrovfsf) = ugwrymvwhi vrxomjhjdt (ylbrzhflxf )
PRNewswire Manual	Phase 3	Triple Negative Breast Cancer \| Hormone receptor positive HER2 negative breast cancer ER Negative \| PR Negative \| HER2 Negative \| ... View more	-	tinengotinib (HR+/HER2- BC)	pwkvvecttp(gkcbuxveiq) = dqltjzvogx jwagjcnipl (fxlxuauugw ) View more	Positive	07 Dec 2023
				tinengotinib (TNBC)	pwkvvecttp(gkcbuxveiq) = ngdxlsrttq jwagjcnipl (fxlxuauugw ) View more
NCT05253053 (ESMO2023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm FGFR2 alteration	33	Tinengotinib	xrixiqexzp(wxleoqkubp) = zvxqtojtza kzsbkeroxd (vgvtmhtxnu ) View more	Positive	23 Oct 2023
				Tinengotinib (measurable target lesions)	rjugmxlbvo(fvqlkudpsg) = niayhrznos nyrzcocoyd (pvsxwasczl ) View more
NCT04742959 \| NCT03654547 \| NCT04919642 (ESMO2023) Manual	Phase 1/2	Bile Duct Neoplasms FGFR2	73	Tinengotinib	wotjhtvqvj(laclgoyrhp) = snsquuiwdl nstzpyllzf (vyicftwbxm ) View more	Positive	21 Oct 2023
				Tinengotinib (FGFR2 alteration who received prior FGFR)	wotjhtvqvj(laclgoyrhp) = sthzdesuan nstzpyllzf (vyicftwbxm ) View more
NCT04742959 (ASCO2023) Manual	Phase 1/2	Solid tumor	157	tinengotinib (12 mg QD)	ebnrxlskib(oqvdbmxuqr) = In 108 efficacy-evaluable pts of monotherapy arms were 60% bnxrbzysfa (cctkdgwctc ) 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	evatjunkrr(vasknmocvp) = 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 efdhmmiflm (vsqqivddwl ) View more	Positive	24 Jan 2023
				tinengotinib (FGFR2 fusion/rearrangement pts)
NCT03654547 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	48	TT-00420	qxdzfesaey(kzhppvciph) = sjlybdkpay vkibjaxbah (xstwujinci ) View more	Positive	02 Jun 2022
NCT03654547 (P-261, ESMO_GI2021)	Phase 1	Advanced biliary tract cancer FGFR2 alteration	9	TT-00420	xgtdjafzmk(prtzuplibo) = obikprjbbn wjonbswfib (ephwqeqnuk )	Positive	03 Jul 2021

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