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Phase I study of BI  1831169 (VSV‑GP) ± ezabenlimab in advanced or metastatic solid tumors

 

Phase I open-label, dose escalation trial of VSV-GP oncolytic virus (BI 1831169) monotherapy and in combination with ezabenlimab (PD-1 inhibitor) in patients with advanced or metastatic solid tumors (NCT05155332)1

NCT05155332 (1456-0001)
NCT05155332 (1456-0001)

AE, adverse event, cRP2D, combination recommended Phase II dose; DLT, dose-limiting toxicity; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GP, glycoprotein; iCR, immunotherapy complete response; iPR, immunotherapy partial response; iRECIST, Immunotherapy Response Evaluation Criteria in Solid Tumours; IT, intratumoral; itCR, intratumoral immunotherapy complete response; itPR, intratumoral immunotherapy partial response; itRECIST, Intratumoral Response Evaluation Criteria in Solid Tumours; IV, intravenous; mRP2D, monotherapy recommended Phase II dose; MTD, maximum tolerated dose; OR, objective response; PD-1, programmed cell death protein-1; PFS, progression-free survival; VSV, vesicular stomatitis. virus.

References

  1. ClinicalTrials.gov. NCT05155332. https://clinicaltrials.gov/ct2/show/NCT05155332 (Accessed: February 2026).