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Phase 2 Study of WGI-0301 for Advanced HCC

NCT06309485 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-19

No results posted yet for this study

Summary

The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.

Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Interventions

DRUG

WGI-0301 at MTD/RP2D dose IV infusion, QW

WGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.

DRUG

WGI-0301 at MTD/RP2D -1 dose IV infusion, QW

WGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.

DRUG

Sorafenib 400 mg PO, BID continuously

Sorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.

DRUG

Sorafenib 400 mg PO, BID

Sorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.

Sponsors & Collaborators

  • Zhejiang Haichang Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • China
  • Hong Kong

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 NCT06309485 on ClinicalTrials.gov