Therapy Detail

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Therapy Name Tinengotinib
Synonyms
Therapy Description

Tinengotinib (TT-00420) is a multikinase inhibitor that targets AURKA, AURKB, FGFR1-3, VEGFR, JAK1/2, and CSF1R, potentially resulting in decreased cell proliferation and inhibition of tumor growth (PMID: 36223547).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Tinengotinib TT00420|TT 00420|TT-00420 Aurka Inhibitors 26 Aurkb Inhibitors 21 CSF1R Inhibitor 28 FGFR1 Inhibitor 28 FGFR2 Inhibitor 23 FGFR3 Inhibitor 19 JAK Inhibitor (Pan) 9 VEGFR Inhibitor (Pan) 36 Tinengotinib (TT-00420) is a multikinase inhibitor that targets AURKA, AURKB, FGFR1-3, VEGFR, JAK1/2, and CSF1R, potentially resulting in decreased cell proliferation and inhibition of tumor growth (PMID: 36223547).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 act mut cholangiocarcinoma predicted - sensitive Tinengotinib Clinical Study Actionable In a combined analysis of 3 clinical trials, Tinengotinib (TT-00420) resulted in an overall response rate (ORR) of 20.7% and disease control rate (DCR) of 75.9% in cholangiocarcinoma patients (n=58), and in patients with FGFR2 mutations (n=29), an ORR of 34% and DCR of 89.7% and ORR of 38.1%, DCR of 95.2%, and median progression-free survival of 6.9 mo in patients with prior FGFR inhibitor resistance (n=21) (Ann Oncol (2023) 34 (suppl_2): S215-S216; NCT03654547, NCT04742959, NCT04919642). detail...
FGFR2 rearrange Her2-receptor negative breast cancer predicted - sensitive Tinengotinib Case Reports/Case Series Actionable In a Phase I trial, Tinengotinib (TT-00420) treatment was well tolerated and resulted in stable disease in 53.3% (23/43) and partial response in 16.3% (7/43) of patients with advanced solid tumors, including a partial response in a patient with hormone receptor-positive, ERBB2 (Her2)-negative breast cancer harboring an FGFR2 rearrangement (PMID: 38297981; NCT03654547). 38297981
FGFR2 C382R cholangiocarcinoma predicted - sensitive Tinengotinib Case Reports/Case Series Actionable In a Phase I trial, Tinengotinib (TT-00420) treatment was well tolerated and resulted in stable disease in 53.3% (23/43) and partial response in 16.3% (7/43) of patients with advanced solid tumors, including a partial response in a patient with cholangiocarcinoma harboring FGFR2 C382R (PMID: 38297981; NCT03654547). 38297981
FGFR2 amp prostate adenocarcinoma predicted - sensitive Tinengotinib Case Reports/Case Series Actionable In a Phase I trial, Tinengotinib (TT-00420) treatment was well tolerated and resulted in stable disease in 53.3% (23/43) and partial response in 16.3% (7/43) of patients with advanced solid tumors, including a partial response in a patient with castration-resistant prostate adenocarcinoma with amplification of FGFR2 (PMID: 38297981; NCT03654547). 38297981

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03654547 Phase I Tinengotinib Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer Active, not recruiting USA 1
NCT05948475 Phase III Tinengotinib Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma (FIRST-308) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT 4
NCT04742959 Phase Ib/II Tinengotinib Nab-paclitaxel + Tinengotinib Study of TT-00420 Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors Completed USA 0
NCT04919642 Phase II Tinengotinib Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma Completed USA 0


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