A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma

A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients With Advanced/Metastatic Hepatocellular Carcinoma

This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.

A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with Advanced/Metastatic Hepatocellular Carcinoma.

Inclusion Criteria:

• Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
• Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
• Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
• Metastatic or locally advanced meeting ANY of the criteria below:
• HCC not suitable to receive local therapy
• Disease recurred or was refractory to last therapy (local or systemic)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks

Exclusion Criteria:

• More than 2 prior systemic treatments for HCC
• Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
• Presence of hepatic encephalopathy within 4 weeks of 1st dose
• Uncontrolled massive ascites
• High likelihood of bleeding