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

Sponsor

Autotelicbio (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04862767

Collaborator

(none)

Enrollment

Location

Arm

12.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide) Combination Product: Aldesleukin	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

3+3 design3+3 design

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 9, 2021

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of MTD (Tolerability) [4weeks(DLT)]
MTD and RP2D are determined

Secondary Outcome Measures

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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults over 19 years old on the day of consent
Pathologically confirmed solid cancer
Patients with advanced or metastatic solid timour failed or tolerable with standard therapy.
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:

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)
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
Immunotherapy within 2 weeks prior to first dose of study treatment.
Major surgery within 4 weeks prior to first dose of study treatment.