Phase I Study Evaluating Safety and Dose Levels of CREPT-618 in Adults With Advanced Hepatocellular Carcinoma Who Have Failed Standard Treatment

What this Trial Is About

Researchers are evaluating the safety and appropriate dosing of CREPT-618 in adults aged 18 to 75 with locally advanced hepatocellular carcinoma who have not responded to standard treatments. This Phase I clinical study uses a dose-escalation design to determine the maximum tolerated dose, optimal biological dose, and recommended dose for future studies, while also assessing pharmacokinetics and preliminary efficacy. The study involves three main dose groups low 0.5 mgkg, medium 1.5 mgkg, and high 4.5 mgkg. Patients receive single or multiple subcutaneous injections of CREPT-618 every two weeks. Starting with one sentinel patient in the low-dose group observed for 28 days, the trial progresses to higher doses based on safety and absence of dose-limiting toxicities. If tolerated, the dose may be increased to 9 mgkg with additional patient enrollment. Disease progression after six weeks may lead to combination treatment with pembrolizumab. Participants will undergo safety evaluations, pharmacokinetic sampling at multiple time points after dosing, and efficacy assessments for up to two years. Researchers will monitor adverse events, drug levels in the blood, and early signs of anti-tumor activity. Follow-up includes checking liver function and patient compliance, with treatment adjustments made as needed based on safety and response.

A Phase I Study of CREPT-618 in Locally Advanced HCC