RecruitingPhase 2NCT06309485

Phase 2 Study of WGI-0301 for Advanced HCC

An Open-Label Phase 1/2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy


Sponsor

Zhejiang Haichang Biotech Co., Ltd.

Enrollment

60 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests a new drug called WGI-0301 in patients with advanced liver cancer (hepatocellular carcinoma, or HCC) whose disease has progressed after standard treatments. The drug targets specific pathways involved in cancer cell survival. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with liver cancer (HCC), either confirmed by biopsy or through standard imaging criteria - Your liver cancer is in an advanced stage (BCLC Stage C, or Stage B with extensive liver involvement) - You have tried at least one standard treatment that did not work, or you cannot tolerate standard treatments **You may NOT be eligible if...** - You have significant liver scarring (cirrhosis) that severely impairs liver function - You are pregnant or breastfeeding - You have uncontrolled infections or other serious medical conditions - You have had a prior liver transplant 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

DRUGWGI-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.

DRUGWGI-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.

DRUGSorafenib 400 mg PO, BID continuously

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

DRUGSorafenib 400 mg PO, BID

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


Locations(4)

China Pharmaceutical University, Shanghai Gobroad Cancer Hospital

Shanghai, Shanghai Municipality, China

West China Hospital Sichuan University

Chengdu, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Prince of Wales Hospital

Hong Kong, Hong Kong

View Full Details on ClinicalTrials.gov

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NCT06309485


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