Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 3:39 AM
Study NCT ID:
NCT06178003
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in Malignant Effusions.
Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Organization:
Study Overview
Official Title:
A Phase I/II Clinical Study of the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in the Treatment of Malignant Pleural and Abdominal Effusions
Status:
RECRUITING
Status Verified Date:
2023-12
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 a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
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?: