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

Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862767
• Other study ID #: ATB-301-001
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2021
• Est. completion date: August 21, 2023

Study information

• Verified date: January 2024
• Source: Autotelicbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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-ß 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• TASO-001((TGF-ß2 targeting anti-sense oligonucleotide)
96 hour continuous infusion

Combination Product:
• Aldesleukin
SC, Bid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Autotelicbio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MTD (Tolerability)	MTD and RP2D are determined	4weeks(DLT)
Secondary	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.	every 8 weeks, and up to 14 days after the last dose of TASO-001
Secondary	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.	every 8 weeks, and up to 14 days after the last dose of TASO-001
Secondary	DoR(Duration of response)	Median, standard deviation and 95% confidential interval of DoR is estimated by the Kaplan-Meier method.	every 8 weeks, and up to 14 days after the last dose of TASO-001
Secondary	PFS(Progression free survival)	: Median, standard deviation and 95% confidential interval of PFS is estimated by the Kaplan-Meier method.	every 8 weeks, up to 14 days after the last dose of TASO-001
Secondary	OS(Overall survival)	: Median, standard deviation, 95% confidential interval of OS is estimated by Kaplan-Meier method.	every 8 weeks, up to 14 days after the last dose of TASO-001