NCT06309485

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhejiang Haichang Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will include a two-stage design: Stage 1 (dose escalation) to determine the MTD/RP2D of WGI-0301 combined with Sorafenib. Stage 2 (dose expansion) with two different dose levels of WGI-0301 in combination with standard dose Sorafenib, or standard dose Sorafenib alone.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-03-13
• Last updated: 2026-03-19

Locations

4 sites across 2 countries: China, Hong Kong

Regulatory

• FDA-regulated drug study