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to evaluate safety, tolerance and efficacy of TASO(TGF-b2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in patients with solid tumor

Multi-center, Open label, Phase Ib clinical trial to evaluate safety, tolerance and efficacy of TASO(TGF-b2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in patients with advanced or metastatic solid tumor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006200
Enrollment
9
Registered
2021-05-28
Start date
2021-03-31
Completion date
Unknown
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Autotelic bio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults over 19 years old on the day of consent 2) Pathologically confirmed solid cancer 3) 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 4) Those who are judged by the investigator to comply with the procedure of this clinical trial specified in the clinical trial protocol 5) A person who voluntarily decides to participate in this clinical trial and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1) Is currently (on the screening visit) participating in or has participated in a trial of an investigational agent or has used an investigational device within 28 days prior to the first dose of trial treatment. 2) Known severe hypersensitivity to the investigational drug(TASO-001), interleukin-2 or their excipient or has history of severe hypersensitivity to other drugs. 3) Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 4) Female patients who are pregnant or breast-feeding. 5) Male or female patients of reproductive potential who are not employing an effective method of birth control during study period. 6) Those who are judged by investigators to be not appropriate to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
Tolerability: determination of MTD and RP2D, Safety: Adverse reaction (including DLT), laboratory tests, electrocardiogram, vital signs

Secondary

MeasureTime frame
Tumor response evaluation: ORR, DCR, DoR, PFS, OS

Countries

Korea, Republic of

Contacts

Public ContactHyo-jeong seo

Autotelic bio

hjseo@autotelic.co.kr+82-70-4286-5066

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026