Date: 2018-10-01
Type of
information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Medivir (Sweden)
Product: MIV-818
Action
mechanism:
- nucleotide . MIV-818 is a liver-targeted nucleotide prodrug.
- MIV-818 is the first oncology drug in development from Medivir’s in-house research.
Disease: advanced liver cancer including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma and liver metastases from solid tumors
Therapeutic
area: Cancer - Oncology
Country: Belgium, UK
Trial
details:
Latest
news:
- • On October 1, 2018, Medivir announced that the first patient has been enrolled and dosed with MIV-818 in a phase I/II study in patients with liver cancer. The purpose of this first-in-human trial is to study the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MIV-818 in patients with advanced liver cancer. It will enroll patients with hepatocellular carcinoma (HCC), as well as patients with intrahepatic cholangiocarcinoma and patients with liver metastases from solid tumors.
- The design of phase I/II study of MIV-818 consists of three parts: a phase Ia study in which individual patients receive escalating doses of MIV-818. This will be followed by a phase Ib study in which the dose is escalated in cohorts of three patients in a 3+3 design in order to identify the recommended phase II dose (RP2D), which will be determined by the trial’s independent safety review committee. In the third and final part of the study two dose expansion cohorts of patients, one with HCC and the other with intrahepatic cholangiocarcinoma, will receive MIV-818 at the RP2D.
- The regulatory application to conduct the study was first reviewed and approved by the United Kingdom Medicinal and Healthcare Products Regulatory Agency (MHRA), and the phase Ia part of the trial will be run at sites in the United Kingdom and Belgium.
Is
general: Yes
