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

NCT04862767 | Completed Phase 1

• 1 other identifier: ATB-301-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Autotelicbio; TASO; ATB-301; TGF-β2; Anti-sense Oligonucleotide; Interleukin-2; Aldesleukin

Outcome Measures

Primary Outcomes (1)

• Incidence of MTD (Tolerability)

  MTD and RP2D are determined

  4weeks(DLT)

Secondary Outcomes (5)

• ORR(objective response rate)

  every 8 weeks, and up to 14 days after the last dose of TASO-001

• DCR(Disease control rate)

  every 8 weeks, and up to 14 days after the last dose of TASO-001

• DoR(Duration of response)

  every 8 weeks, and up to 14 days after the last dose of TASO-001

• PFS(Progression free survival)

  every 8 weeks, up to 14 days after the last dose of TASO-001

• OS(Overall survival)

  every 8 weeks, up to 14 days after the last dose of TASO-001

Study Arms (1)

TASO-001

EXPERIMENTAL

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); Combination Product: Aldesleukin

Interventions

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

96 hour continuous infusion

TASO-001

Aldesleukin COMBINATION_PRODUCT

SC, Bid

TASO-001

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autotelicbio: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

aldesleukin

Study Officials

• James Jun, M.D.

  Autotelicbio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 design

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 28, 2021
• Study Start: March 9, 2021
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

KR (1)