Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309485
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-01
Brief Title:
Phase 2 Study of WGI-0301 for Advanced HCC
Sponsor:
Zhejiang Haichang Biotech Co Ltd
Organization:
Zhejiang Haichang Biotech Co Ltd
Study Overview
Official Title:
An Open-Label Phase 2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 MTDRP2D 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None