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Completed

NCT Number: NCT04862767

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

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.

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Key information

Conditions

Solid Tumor

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

96 hour continuous infusion

Aldesleukin

Combination Product

SC, Bid

Primary outcomes

  1. Incidence of MTD (Tolerability)

    Time frame: 4weeks(DLT)

    MTD and RP2D are determined

Secondary outcomes

  1. ORR(objective response rate)

    Time frame: 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.

  2. DCR(Disease control rate)

    Time frame: 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.

  3. DoR(Duration of response)

    Time frame: 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.

  4. PFS(Progression free survival)

    Time frame: 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.

  5. OS(Overall survival)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Autotelicbio

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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