Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154291
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-11-06
Brief Title:
FIH XON7 in AdvancedMetastatic Solid Tumors
Sponsor:
Xenothera SAS
Organization:
Xenothera SAS
Study Overview
Official Title:
Phase III Multi Center Open Label First-in-human Dose Escalation and Expansion Study to Investigate the Safety Pharmacokinetics and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
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:
FIPO23
Brief Summary:
This is a two-stage trial consisting of a Part I dose escalation and dose-finding component to establish the Maximal Tolerated Dose MTD if any and Recommended Part 2 Dose RP2D of XON7 followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505266-29-00 | OTHER | EU CT number | None |