Clinical trial NCT04862767: TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Autotelicbio
TASO
ATB-301
TGF-β2
Anti-sense Oligonucleotide
Interleukin-2
Aldesleukin
Lead sponsor: Autotelicbio
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 3+3 design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of MTD (Tolerability)
timeFrame: 4weeks(DLT)
Secondary outcomes:
measure: ORR(objective response rate)
timeFrame: every 8 weeks, and up to 14 days after the last dose of TASO-001
measure: DCR(Disease control rate)
timeFrame: every 8 weeks, and up to 14 days after the last dose of TASO-001
measure: DoR(Duration of response)
timeFrame: every 8 weeks, and up to 14 days after the last dose of TASO-001
measure: PFS(Progression free survival)
timeFrame: every 8 weeks, up to 14 days after the last dose of TASO-001
measure: OS(Overall survival)
timeFrame: every 8 weeks, up to 14 days after the last dose of TASO-001
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Autotelicbio
name: James Jun, M.D.
role: STUDY_DIRECTOR
References: