Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-07 @ 1:31 AM
Study NCT ID:
NCT06410092
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001
Sponsor:
Sound Biopharmaceuticals Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL001 in Patients With Advanced or Metastatic Solid Tumors
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 is an open, multi-center, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics and initial efficacy of FTL001 in patients with advanced and metastatic solid tumors.
Detailed Description:
The study is divided into two phases, Part 1 (FTL001 dose escalation) and Part 2 (FTL001 dose expansion), and is intended to include approximately 26-44 participants.
Study Oversight
Has Oversight DMC:
False
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?: