Trial reportNature communications2026
The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a phase Ib/II trial.
Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05253053 (A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor), which is not on this map. Not yet cited in PubMed.
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A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor
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18 authors.
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Abstract
Tinengotinib is a spectrum-selective multi-kinase inhibitor targeting FGFR1-3, JAK1/2, VEGFRs, and Aurora A/B kinases. This phase Ib/II clinical trial ( NCT05253053 ) evaluated tinengotinib as monotherapy (Arm A, n = 53, in Chinese patients with advanced solid tumors) and in combination with atezolizumab (Arm B, n = 31, in patients with advanced biliary tract cancer). Each arm comprised a dose-escalation phase with standard 3 + 3 design (phase Ib) followed by a dose-expansion phase (phase II). The primary endpoints of the phase Ib were safety, tolerability, dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and dose selection for expansion, with secondary endpoints of efficacy (phase II) and pharmacokinetics. The trial met pre-specified primary endpoints: tinengotinib was well tolerated without DLTs, and MTD was not reached. Tinengotinib demonstrated antitumor activity both as monotherapy (objective response rate [ORR]: 16.7% in Arm A) and combined with atezolizumab (ORR: 22.6% in Arm B). In predefined exploratory subgroup analysis, notable efficacy was observed in cholangiocarcinoma (ORR: 30.8% in Arm A [n = 13]; 25.0% in Arm B [n = 28]). Tinengotinib monotherapy achieved favorable response in cholangiocarcinoma harboring FGFR2 fusion progressing on prior FGFR inhibitor (ORR: 66.7%). In patients with cholangiocarcinoma previously treated with immune checkpoint inhibitors (n = 20), the combination regimen achieved an ORR of 20.0% and a disease control rate of 75.0%. These findings support further development of tinengotinib, both as monotherapy and in combination with immunotherapy.
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