Solid Tumor
Conditions
Keywords
Autotelicbio, TASO, ATB-301, TGF-β2, Anti-sense Oligonucleotide, Interleukin-2, Aldesleukin
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.
Interventions
DRUGTASO-001((TGF-β2 targeting anti-sense oligonucleotide)
96 hour continuous infusion
COMBINATION_PRODUCTAldesleukin
SC, Bid
Sponsors
Autotelicbio
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3+3 design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MTD (Tolerability) | 4weeks(DLT) | MTD and RP2D are determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed