NCT04862767

TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Autotelicbio · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	TASO-001((TGF-β2 targeting anti-sense oligonucleotide)	96 hour continuous infusion
COMBINATION_PRODUCT	Aldesleukin	SC, Bid

Timeline

• Start date: 2021-03-09
• Primary completion: 2023-08-21
• Completion: 2023-08-21
• First posted: 2021-04-28
• Last updated: 2024-01-31

Locations

1 site across 1 country: South Korea