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Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid

Mercedes Porosnicu1, Anne-Marie Quinson2, Kate Crossley3

  • 1Department of Internal Medicine, Section on Hematology & Oncology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.

Future Oncology (London, England)
|June 14, 2022
PubMed

Insights

This study investigates a novel oncolytic virus therapy (VSV-GP) and its combination with an immune checkpoint inhibitor (ezabenlimab) for advanced solid tumors. The phase I trial assesses safety and efficacy in patients with poor prognosis.

Area of Science:

  • Oncology
  • Immunotherapy
  • Virology

Background:

  • Patients with advanced, recurrent, or metastatic cancers face poor prognoses despite current treatments.
  • Vesicular stomatitis virus (VSV)-glycoprotein (GP; BI 1831169) is a recombinant oncolytic virus engineered for tumor-specific activity.
  • Preclinical studies show VSV-GP effectively targets tumors, induces cell death (oncolysis), and stimulates anti-tumor immunity.

Purpose of the Study:

  • To evaluate the safety and tolerability of VSV-GP.
  • To determine the optimal dose of VSV-GP when administered alone and in combination with ezabenlimab.
  • To explore the preliminary efficacy of this combination therapy in patients with advanced solid tumors.

Main Methods:

  • Phase I, dose-escalation clinical trial (NCT05155332).
  • Recruitment of patients with advanced, metastatic, or relapsed/refractory solid tumors.
  • Administration of VSV-GP alone and in combination with ezabenlimab (BI 754091).

Main Results:

  • This section will be populated once the study is completed and results are available.
  • Data on dose-limiting toxicities and maximum tolerated dose will be reported.
  • Preliminary efficacy data, including response rates and duration of response, will be analyzed.

Conclusions:

  • The combination of VSV-GP and ezabenlimab presents a promising novel therapeutic strategy for advanced solid tumors.
  • Further clinical trials are warranted to confirm the efficacy and safety of this combination therapy.
  • This approach has the potential to improve outcomes for patients with limited treatment options.
Keywords:
cancerclinical trialsimmunotherapyoncologyoncolytic virussolid tumors

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