The study is a multicenter open-label, dose escalation, Phase 1b safety and tolerability study in patients with liver metastases of solid tumor of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBL0102. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and response to CBL0102.
The study includes a dose escalation arm of up to 30 patients divided into five cohorts, with an additional six patients to be enrolled at the selected therapeutic dose. Patients will be treated with CBL0102 for eight weeks, with a loading dose administered in week 1 and maintenance doses administered in weeks 2-8. Dose escalation will be done gradually, starting with a loading dose of 300mg and a maintenance dose of 100mg. Recruitment is anticipated to take approximately six months, with overall duration of the study to last approximately 12 months.
The lead center for the study is the Russian Oncological Scientific Center (ROSC) in Moscow, a leading oncology center in Russia. The national coordinator for the study is Professor S.A. Tyulyandin, MD, D.Sc., Deputy Director of Clinical Oncology and Director of Clinical Pharmacology and Chemotherapy at ROSC.