Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:13 PM
Study NCT ID:
NCT04862767
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor
Sponsor:
Autotelicbio
Organization:
Study Overview
Official Title:
Multi-center, Open Label, Phase Ib Clinical Trial to Evaluate Safety, Tolerance and Efficacy of TASO(TGF-β2 Targeting Anti-sense Oligonucleotide)-001 in Combination With Recombinant Interleukin-2 in Advanced or Metastatic Solid Tumor
Status:
COMPLETED
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:
None
Brief Summary:
To evaluate safety, tolerance and efficacy of TASO(TGF-β2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in advanced or metastatic solid tumor and to find appropriate dose for phase 2 clinical trial.
Detailed Description:
This clinical trial is conducted by dividing into two cohorts according to the dose of the test drug, starting with Cohort 1, and confirming whether DLT occurs until 14 days after the 2nd cycle of the test drug administration and proceed with Cohort 2 after discussion by DMC. Recruitment of each cohort is applied with a 3+3 design.
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?: