Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04740424
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2021-01-28
Brief Title:
FS222 First in Human Study in Patients With Advanced Malignancies
Sponsor:
invoX Pharma Limited
Organization:
invoX Pharma Limited
Study Overview
Official Title:
A Phase 1 Open-Label First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222 a CD137PD-L1 Bispecific Antibody in Subjects With Advanced Malignancies
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety tolerability pharmacokinetics PK and activity of FS222 This is a Phase 1 multi-center open label multiple-dose first in human study designed to systematically assess safety and tolerability and to identify the maximum tolerated dose MTD andor recommended Phase 2 dose RP2D for FS222 in participants with advanced tumours Pharmacokinetics pharmacodynamics immunogenicity and response will also be assessed
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