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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide); Combination product: Aldesleukin

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: hyojeong Seo; Phone Number: 823180818780; Email: hjseo@autotelic.co.kr
• Study Contact Backup: Name: Juneui Park, Ph.D; Phone Number: 823180818780; Email: juneui.park@autotelic.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults over 19 years old on the day of consent
2. Pathologically confirmed solid cancer
3. Patients with advanced or metastatic solid timour failed or tolerable with standard therapy.
4. A person who has a tumor lesion that can safely undergo tissue biopsy during administration of the test drug and can provide tissues stored at the clinical trial agency or tissue obtained from a tissue biopsy conducted before the first administration of the test drug

Exclusion Criteria:

1. Those who have been treated with IL-2 or TGF-β inhibitors other than test drugs (e.g., anti-sense oligonucleotide, antibody, TGF-b receptor inhibitor)
2. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Immunotherapy within 2 weeks prior to first dose of study treatment.
4. Major surgery within 4 weeks prior to first dose of study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TASO-001; level 1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)(3+3) next than level 2 or level -1 of TASO-001 in combination with recombinant IL-2(Aldesleukin)	Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide); 96 hour continuous infusion; Combination product: Aldesleukin; SC, Bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MTD (Tolerability)	MTD and RP2D are determined	4weeks(DLT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR(objective response rate)	In case the best overall response expressed as CR or PR by RECIST v1.1 and iRECIST, the rate of subjects should be presented for each dose group.	every 8 weeks, and up to 14 days after the last dose of TASO-001
DCR(Disease control rate)	In case the best overall response expressed as CR, PR or SD by RECIST v1.1 and iRECIST, the rate of subjects should be presented for each dose group.	every 8 weeks, and up to 14 days after the last dose of TASO-001
DoR(Duration of response)	Median, standard deviation and 95% confidential interval of DoR is estimated by the Kaplan-Meier method.	every 8 weeks, and up to 14 days after the last dose of TASO-001
PFS(Progression free survival)	: Median, standard deviation and 95% confidential interval of PFS is estimated by the Kaplan-Meier method.	every 8 weeks, up to 14 days after the last dose of TASO-001
OS(Overall survival)	: Median, standard deviation, 95% confidential interval of OS is estimated by Kaplan-Meier method.	every 8 weeks, up to 14 days after the last dose of TASO-001

Collaborators and Investigators

• Sponsor: Autotelicbio
• Investigators: Study Director: James Jun, M.D., Autotelicbio

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Interleukin-2; Aldesleukin; Autotelicbio; TASO; ATB-301; TGF-β2; Anti-sense Oligonucleotide
• Additional Relevant MeSH Terms: Neoplasms; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Aldesleukin
• Other Study ID Numbers: ATB-301-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No