Solid TumorPhase 1NCT04862767
TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor
A Phase 1 study testing TASO-001((TGF-β2 targeting anti-sense oligonucleotide) and Aldesleukin in people with Solid Tumor, run by Autotelicbio at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- TASO-001((TGF-β2 targeting anti-sense oligonucleotide) and Aldesleukin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2021to 21 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Solid Tumor
- Being tested
- TASO-001((TGF-β2 targeting anti-sense oligonucleotide), Aldesleukin
- Keywords
- Autotelicbio, TASO, ATB-301, TGF-β2, Anti-sense Oligonucleotide, Interleukin-2, Aldesleukin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASO-001((TGF-β2 targeting anti-sense oligonucleotide)Drug
96 hour continuous infusion
AldesleukinCombination product
SC, Bid
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide); Combination Product: Aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MTD (Tolerability)
MTD and RP2D are determined
Measured: 4weeks(DLT)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: every 8 weeks, up to 14 days after the last dose of TASO-001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start9 Mar 2021
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autotelicbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Jun, M.D., Study director, Autotelicbio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862767
- Sponsor's protocol ID
- ATB-301-001
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04862767
- Acronym / sponsor ID
- ATB-301-001
- Conditions
- Solid Tumor
- Keywords
- Autotelicbio, TASO, ATB-301, TGF-β2, Anti-sense Oligonucleotide, Interleukin-2, Aldesleukin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AutotelicbioIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 design
| Arm | Type | Receives |
|---|---|---|
| TASO-001 | Experimental | Drug: TASO-001((TGF-β2 targeting anti-sense oligonucleotide), Combination Product: Aldesleukinlevel 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TASO-001((TGF-β2 targeting anti-sense oligonucleotide)96 hour continuous infusion | Drug | TASO-001 |
| AldesleukinSC, Bid | Combination product | TASO-001 |
Primary outcome
Incidence of MTD (Tolerability)
Time frame: 4weeks(DLT)
MTD and RP2D are determined
5 secondary outcomes
ORR(objective response rate)
Time frame: every 8 weeks, and up to 14 days after the last dose of TASO-001
DCR(Disease control rate)
Time frame: every 8 weeks, and up to 14 days after the last dose of TASO-001
DoR(Duration of response)
Time frame: every 8 weeks, and up to 14 days after the last dose of TASO-001
PFS(Progression free survival)
Time frame: every 8 weeks, up to 14 days after the last dose of TASO-001
OS(Overall survival)
Time frame: every 8 weeks, up to 14 days after the last dose of TASO-001
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Jun, M.D. study director
Autotelicbio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TASO-001((TGF-β2 targeting anti-sense oligonucleotide) and Aldesleukin in people with Solid Tumor, run by Autotelicbio at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MTD (Tolerability) (time frame: 4weeks(DLT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.