drugset / Trial / NCT03781934

A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations

NCT03781934

Phase 1/2 Completed 53 enrolled Medivir
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicentre dose escalation/expansion study to assess safety and tolerability of MIV 818 as either monotherapy or in combination with 1) lenvatinib, a tyrosine kinase inhibitor used as a standard of care for the treatment of HCC or 2) pembrolizumab, a PD-1 inhibitor. The monotherapy parts of the study will include patients with various solid tumours that have spread to the liver, or alternatively originating in the liver. Evaluations of MIV-818 in combination with lenvatinib or pembrolizumab will only include patients with HCC.

Timeline

Start
2018-09-05
Primary completion
2025-01-07
Completion
2025-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject fostroxacitabine bralpamide Small molecule Oral
Background Lenvatinib Small molecule Oral
Background Pembrolizumab Monoclonal antibody Intravenous