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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide)
* Combination Product: Aldesleukin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: 3+3 design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASO-001<br>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)<br>* 96 hour continuous infusion<br>Combination Product: Aldesleukin<br>* SC, Bid<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autotelicbio, TASO, ATB-301, TGF-β2, Anti-sense Oligonucleotide, Aldesleukin, Interleukin-2