Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349980
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-01
Brief Title:
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Patients
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Randomized Double-blind Multi-center Phase II Study to Evaluate the Anti-tumor Efficacy Safety and Tolerability of HLX53 an Anti-TIGIT Fc Fusion Protein Combined With Serplulimab Injection HLX10 a Recombinant Anti-PD-1 Antibody and HLX04 a Biosimilar to Bevacizumab Compared to Placebo Serplulimab HLX04 in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 study is being conducted to to explore the reasonable dosage and evaluate the efficacy safety and tolerability of Serplulimab Injection HLX10 a Recombinant Anti-PD-1 Antibody and HLX04 a Biosimilar to Bevacizumab With or Without HLX53 an Anti-TIGIT Fc Fusion Protein in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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