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

Autotelicbio9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

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

96 hour continuous infusion

AldesleukinCOMBINATION_PRODUCT

SC, Bid

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of MTD (Tolerability)

MTD and RP2D are determined

Time frame: 4weeks(DLT)

Secondary Outcomes

ORR(objective response rate)

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.

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

DCR(Disease control rate)

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.

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

DoR(Duration of response)

Median, standard deviation and 95% confidential interval of DoR is estimated by the Kaplan-Meier method.

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

PFS(Progression free survival)

: Median, standard deviation and 95% confidential interval of PFS is estimated by the Kaplan-Meier method.

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

OS(Overall survival)

: Median, standard deviation, 95% confidential interval of OS is estimated by Kaplan-Meier method.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.