Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT05141357
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer
Sponsor:
HUYABIO International, LLC.
Organization:
Study Overview
Official Title:
A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination With Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBI-8000
Brief Summary:
A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Detailed Description:
This Phase 2 study evaluates HBI-8000, a histone deacetylase inhibitor (HDACi) in combination with pembrolizumab for the treatment of patients with advanced or metastatic non-small cell lung cancer who possess programmed death ligand 1 (PD-L1) expression Tumor Proportion Score (TPS) of 1% or greater.
The Treatment Phase allowed for up to 24 months of treatment (cycles were 21 days), providing the subject did not experience disease progression or unacceptable toxicity.
The Treatment Phase allowed for up to 24 months of treatment (cycles were 21 days), providing the subject did not experience disease progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
False
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?: