The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a

Panpan Zhang1, Zuoxing Niu2, Hongqian Guo3

  • 1Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute, Beijing, 100142, China.

Insights

Tinengotinib, a multi-kinase inhibitor, showed good safety and antitumor activity in advanced solid tumors. It demonstrated promise in cholangiocarcinoma, especially when combined with atezolizumab.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Tinengotinib is a novel multi-kinase inhibitor targeting FGFR, JAK, VEGFR, and Aurora kinases.
  • Advanced solid tumors, particularly biliary tract cancer, present significant treatment challenges.

Purpose of the Study:

  • To evaluate the safety, tolerability, and efficacy of tinengotinib as monotherapy and in combination with atezolizumab.
  • To determine the maximum tolerated dose (MTD) and select doses for phase II expansion.

Main Methods:

  • A phase Ib/II clinical trial (NCT05253053) with dose-escalation and expansion phases.
  • Tinengotinib was administered as monotherapy (Arm A) or combined with atezolizumab (Arm B) in patients with advanced solid tumors and biliary tract cancer.

Main Results:

  • Tinengotinib was well-tolerated, with no dose-limiting toxicities (DLTs) or MTD reached.
  • Objective response rates (ORR) were 16.7% for tinengotinib monotherapy and 22.6% for the combination regimen.
  • Notable efficacy was observed in cholangiocarcinoma, with ORRs of 30.8% (monotherapy) and 25.0% (combination).

Conclusions:

  • Tinengotinib is safe and demonstrates antitumor activity in advanced solid tumors.
  • The combination of tinengotinib and atezolizumab shows potential for treating biliary tract cancer, supporting further clinical development.

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