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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide); Combination Product: Aldesleukin

• Registration Number: NCT04862767
• Lead Sponsor: Autotelicbio

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 Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TASO-001	TASO-001((TGF-β2 targeting anti-sense oligonucleotide)	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)
TASO-001	Aldesleukin	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)

Primary Outcome Measures

Name	Time	Method
Incidence of MTD (Tolerability)	4weeks(DLT)	MTD and RP2D are determined

Secondary Outcome Measures

Name	Time	Method
PFS(Progression free survival)	every 8 weeks, up to 14 days after the last dose of TASO-001	: Median, standard deviation and 95% confidential interval of PFS is estimated by the Kaplan-Meier method.
DCR(Disease control rate)	every 8 weeks, and up to 14 days after the last dose of TASO-001	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.
OS(Overall survival)	every 8 weeks, up to 14 days after the last dose of TASO-001	: Median, standard deviation, 95% confidential interval of OS is estimated by Kaplan-Meier method.
ORR(objective response rate)	every 8 weeks, and up to 14 days after the last dose of TASO-001	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.
DoR(Duration of response)	every 8 weeks, and up to 14 days after the last dose of TASO-001	Median, standard deviation and 95% confidential interval of DoR is estimated by the Kaplan-Meier method.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of