This is a Phase 1, open-label, multicenter, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CT-01, administered either as monotherapy or in combination with everolimus. The study population includes subjects with intermediate or advanced hepatocellular carcinoma (HCC) who have progressed on, or are intolerant to, at least one prior line of systemic treatment. All available standard-of-care therapies should have been received, if deemed appropriate by the investigator (unless contraindicated or considered inappropriate by the treating physician). Eligible subjects are classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C and must not be amenable to curative treatment approaches. Only subjects with preserved liver function (Child-Pugh Class A, score 5-6) at screening are eligible. Approximately 141 participants will be enrolled across 20 sites in Europe (France, Spain, and Germany).
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Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy
Timeframe: Up to 12 months
Maximum tolerated dose (MTDm) of CT-01 monotherapy
Timeframe: Up to 12 months
Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy
Timeframe: Up to 12 months
Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus
Timeframe: Up to 12 months