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
- Conditions
- Neoplasms
- Registration Number
- KCT0006200
- Lead Sponsor
- Autotelic bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 9
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability: determination of MTD and RP2D, Safety: Adverse reaction (including DLT), laboratory tests, electrocardiogram, vital signs
- Secondary Outcome Measures
Name Time Method Tumor response evaluation: ORR, DCR, DoR, PFS, OS