Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410131
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-30
Brief Title:
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL00816
Sponsor:
Sound Biopharmaceuticals Ltd
Organization:
Sound Biopharmaceuticals Ltd
Study Overview
Official Title:
A Phase 1 First-in-Human Open-Label Dose Escalation and Dose Expansion Study of FTL00816 a Recombinant Anti-CD137 and Anti-5T4 Bispecific Antibody in Patients With Advanced or Metastatic Solid Tumors
Status:
NOT_YET_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 is an open multi-center multi-cohort phase I clinical study designed to evaluate safety tolerability pharmacokinetics and initial efficacy of FTL00816 in patients with advanced and metastatic solid tumors
Detailed Description:
This study is divided into two phases Part 1dose escalation of FTL00816 and Part 2dose extension of FTL00816 which is intended to include about 40 to 68 subjects
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