Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567015
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer NSCLC Resistant to EGFR Tyrosine Kinase Inhibitors TKIs
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STX-241 FIH
Brief Summary:
The goal of this First-In-Human FIH Phase III trial is to establish the safety profile determine the Recommended Phase II Dose RP2D explore the pharmacokinetic PK exposure and pharmacodynamic PD properties as well as assess the efficacy of STX-241 a mutant selective Central Nervous System CNS-penetrant fourth generation EGFR TKI in participants with locally advanced or metastatic NSCLC that progressed during or following third generation EGFR TKI such as osimertinib due to C797X double acquired secondary mutations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None