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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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Tinengotinib | TT00420|TT 00420|TT-00420 | Aurka Inhibitors 27 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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 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 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 |
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... |
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 |
NCT04919642 | Phase II | Tinengotinib | Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma | Completed | USA | 0 |
NCT05948475 | Phase III | Tinengotinib | Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma (FIRST-308) | Recruiting | USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 3 |
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 |