NCT03781934

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

A Phase 1/2a Study in 3 Parts to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients With Liver Cancer Manifestations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Medivir · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Once pre-defined criteria for starting phase 1b monotherapy has been met among the enrolled patients in phase 1a, the next phase of the study will be initiated. Phase 1b monotherapy will enroll up to 30 patients in a 3+3 design with interpatient dose escalations. All dose escalation decisions will be made by a safety review committee that will meet regularly during the study conduct. When the MTD has been established, the SRC will provide a RP2D for monotherapy. Phase 1b combination constitutes an interpatient dose escalation to identify the RP2D for MIV-818 when used in combination with 1) lenvatinib and 2) pembrolizumab therapy. This part of the study will enroll up to 36 patients in a 3+3 design with interpatient dose escalations. Safety review will be performed by the SRC to determine the RP2D of MIV 818 for use in combination with lenvatinib and pembrolizumab. The SRC may recommend that the selected dose of MIV-818 is further evaluated in up to 30 patients in the Phase 2a expansion part of the study.

Conditions

• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Metastases

Interventions

Type	Name	Description
DRUG	MIV-818 (fostroxacitabine bralpamide) + pembrolizumab	MIV-818 - oral capsules; pembrolizumab - IV
DRUG	MIV-818 (fostroxacitabine bralpamide) + lenvatinib	MIV-818 - oral capsules; lenvatinib - oral capsules

Timeline

• Start date: 2018-09-05
• Primary completion: 2025-01-07
• Completion: 2025-06-16
• First posted: 2018-12-20
• Last updated: 2025-07-01

Locations

18 sites across 4 countries: Belgium, South Korea, Spain, United Kingdom