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

This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment. The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.

NCT Number	NCT07364357
Lead Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions	Hepatocellular Carcinoma (HCC)
Enrollment	13 participants
Start Date	2025-09-15
Primary Completion	2026-08-15 (estimated)
Study Completion	2027-09-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-23