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

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Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Combination Product: Aldesleukin; Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04862767

ATB-301-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 1 patient group

TASO-001

Experimental group

Description:

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)

Treatment:

Combination Product: Aldesleukin

Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide)