Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332755
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-16
Brief Title:
Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors
Sponsor:
LG Chem
Organization:
LG Chem
Study Overview
Official Title:
A Phase 1 First-in-Human Open-Label Multi-Center Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
LB-LR1109
Brief Summary:
This is a Phase 1 first-in-human FIH multi-center open-label non-randomized dose escalation study designed to determine the Maximum tolerated doseMTDRecommended Phase 2 doseRP2D of LB-LR1109 and to evaluate safety tolerability preliminary efficacy pharmacokinetics immunogenicity pharmacodynamics of LB-LR1109 and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancerNSCLC head and neck squamous cell carcinomaHNSCC renal cell carcinomaRCC urothelial carcinoma or malignant melanoma and no available standard of care treatment options
Detailed Description:
None
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