Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622486
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
First-in-human Trial of EGL-001 in Patients with Selected Advanced Andor Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First-in-human Phase 12 Trial of EGL-001 in Adult Patients with Selected Advanced Andor 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter open-label first-in-human Phase 12 study consists of a Part 1 Phase 1 open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PDL-1 treatment followed by a Part 2 Phase 2 open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent andor metastatic solid tumors as monotherapy andor combination therapy with anti-PDL-1
Detailed Description:
In approximately 4 centers in France and 4 centers in Spain 30 to 50 patients will be included in the dose escalation Part 1 of the trial Number of participating countries and sites as well as patients will be defined based on Part 1 for Part 2 dose expansion phase
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