Last updated on March 2020

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

Brief description of study

This is a multicentre, open-label study to assess safety and tolerability of MIV-818 in patients with various solid tumours that have spread to the liver, or alternatively originating in the liver.

Detailed Study Description

This study will be conducted in three phases. The initial phase, 1a, will enroll up to 12 subjects and include a total of one dose escalation per patient. All patients will receive an initial probe dose before entering the actual treatment cycles. Once pre-defined criteria for starting phase 1b has been met among the enrolled patients in phase 1a, the next phase of the study will be initiated. Phase 1b will enroll up to 30 patients in a 3+3 design with interpatient dose escalations. All dose escalation decisions will be made by an independent safety review committee that will meet regularly during the study conduct. As the MTD has been met, the SRC will provide a RP2D which will initiate phase 2a of the study. In phase 2a only HCC and iCCA patients will be recruited into two expansion cohorts.

Clinical Study Identifier: NCT03781934

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