RecruitingPhase 1NCT07364357

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

An Open-label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CREPT-618 in Patients With Locally Advanced Hepatocellular Carcinoma


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

13 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called CREPT-618 — an experimental therapy designed to target liver cancer cells — in patients with locally advanced or metastatic hepatocellular carcinoma (HCC, the most common type of primary liver cancer) who have already tried standard treatments without success. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of advanced hepatocellular carcinoma - You have previously tried standard treatments and they did not work - You have inactive (not actively replicating) hepatitis B infection - Your liver cancer tissue tests positive for specific proteins the therapy targets (CREPT and ASGPR) - Your overall health and organ function are adequate for treatment **You may NOT be eligible if...** - You have active, replicating hepatitis B virus - You have not failed any prior standard treatment - Your overall health is too poor (ECOG score above 2) - Your liver, kidney, or blood counts are too low to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICgene therapy

Using small nucleic acid drug to targeting CREPT


Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT07364357


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