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

NCT07364357 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

GENETIC

gene therapy

Using small nucleic acid drug to targeting CREPT

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Ning Li, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-08-15
Completion
2027-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364357 on ClinicalTrials.gov