Locally Advanced (Unresectable) or Metastatic Solid TumorsPhase 1NCT05978492
A Study of TXN10128 in Subjects With Solid Tumors
A Phase 1 study testing TXN10128, Irinotecan and Paclitaxel in people with Locally Advanced (Unresectable) or Metastatic Solid Tumors, run by Txinno Bioscience Inc. at 6 sites in South Korea.
Trial summary
This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced (Unresectable) or Metastatic Solid Tumors
- What is being tested?
- TXN10128, Irinotecan and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 27 Jul 2023to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Male or female subjects ≥19 years of age at the time of informed consent.
- Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
Who cannot join
- Has leptomeningeal disease.
- Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
- Prior organ transplantation.
- Known positive human immunodeficiency virus (HIV) infection.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Chungbuk National University Hospital
Cheonju, North Chungcheong, 28644
Ki-hyeong Lee, MD, PhD
Ki-hyeong Lee, MD, PhD
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Joo-Hwan Park, MD, PhD
Joo-Hwan Park, MD, PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
SeHyun Kim, MD, PhD
SeHyun Kim, MD, PhD
- Recruiting
Seoul National Univ. Hospital
Seoul, Seoul, 03080
Do-Youn Oh, M.D., Ph.D.
Do-Youn Oh, M.D., Ph.D.
- Recruiting
Asan Medical Center
Seoul, Seoul, 05505
Min-Hee Ryu, M.D., Ph.D.
Min-Hee Ryu, M.D., Ph.D.
- Recruiting
SAMSUNG Medical Center
Seoul, 06351
Jin Seok Ahn, MD, PhD
Jin Seok Ahn, MD, PhD
About this study
Official title: A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors
This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors.
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.
Read the detailed description
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part. The study includes dose-escalation and dose-expansion parts across three cohorts: TXN10128 monotherapy (Cohorts A) TXN10128 + Irinotecan (Cohorts B) and TXN10128+ Paclitaxel (Cohorts C).
- Being tested
- TXN10128, Irinotecan, Paclitaxel
- Keywords
- ENPP1, ENPP1 inhibitor, TXN10128, TxinnoBio, Txinno Bioscience, Innate immune, STING pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXN10128Drug
TXN10128: Oral administration once daily everyday
IrinotecanDrug
Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
PaclitaxelDrug
IV administration at 80 mg/m2 three times (Day 1, Day 8, and Day 15) at intervals of 1 week in one cycle (IV administration at 90 mg/m2 for patients with breast cancer)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A-1 | Experimental | TXN10128 Monotherapy Dose esclation part Receives: Drug: TXN10128 |
| Cohort B-1 | Experimental | Combination Therapy with TXN10128 and Irinotecan Dose esclation part Receives: Drug: TXN10128; Drug: Irinotecan |
| Cohort C-1 | Experimental | Combination therapy with TXN10128 and Paclitaxel Dose esclation part Receives: Drug: TXN10128; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
A DLT is defined as any of the following AEs (graded using NCI CTCAE v5.0) whose relationship to TXN10128 cannot be ruled out.
Measured: Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period
Adverse events (AE)
Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level
Measured: Up to 30 days from end of treatment
Secondary outcomes (11)
Cmax
The time to reach the maximum observed concentration (time)
Measured: Up to 21 days from Day 1 dose
AUC inf
The area under the concentration-time curve extrapolated to infinity (mass*time/volume)
Measured: Up to 21 days from Day 1 dose
AUC last
The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass* time/volume)
Measured: Up to 21 days from Day 1 dose
Tmax
The time to reach the maximum observed concentration (time)
Measured: Up to 21 days from Day 1 dose
T1/2
Elimination half-life, determined as 0.693/Lambda_z (time)
Measured: Up to 21 days from Day 1 dose
Vss
Volume of distribution during the steady state phase (volume)
Measured: Up to 21 days from Day 1 dose
Best overall response (BOR)
Best overall response will be summarized
Measured: Up to 30 days from end of treatment
Progression free survival (PFS)
The survival function will be estimated using the Kaplan-Meier product limit method. Median duration, with a two-sided Brookmeyer-Crowley 90% confidence interval and Kaplan-Meier estimates of survival proportions will be provided at specified time points.
Measured: Up to 30 days from end of treatment
Disease control rate (DCR)
The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
Measured: Up to 30 days from end of treatment
Duration of Response (DOR)
Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due to study indication. Estimates will use Kaplan-Meier method
Measured: Up to 30 days from end of treatment
Overall response rate (ORR)
Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).
Measured: Up to 30 days from end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced (Unresectable) or Metastatic Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Txinno Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Hee Ryu, M.D., Ph.D., Principal investigator, Asan Medical CenterDo-Youn Oh, M.D., Ph.D., Principal investigator, Seoul National University HospitalJin Seok Ahn, M.D., Ph.D., Principal investigator, Samsung Medical CenterSeHyun Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang HospitalKi-hyeong Lee, M.D., Ph.D., Principal investigator, Chungbuk National University HospitalJoo-Hwan Park, M.D., Ph.D., Principal investigator, eoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978492
- Sponsor's protocol ID
- TXN10128-01
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05978492
- Acronym / sponsor ID
- TXN10128-01
- Keywords
- ENPP1, ENPP1 inhibitor, TXN10128, TxinnoBio, Txinno Bioscience, Innate immune, STING pathway
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Txinno Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Aug 2023 (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.
This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors.
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.
Detailed description
This study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part. The study includes dose-escalation and dose-expansion parts across three cohorts: TXN10128 monotherapy (Cohorts A) TXN10128 + Irinotecan (Cohorts B) and TXN10128+ Paclitaxel (Cohorts C).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study.
| Arm | Type | Receives |
|---|---|---|
| Cohort A-1 | Experimental | Drug: TXN10128TXN10128 Monotherapy Dose esclation part |
| Cohort B-1 | Experimental | Drug: TXN10128, Drug: IrinotecanCombination Therapy with TXN10128 and Irinotecan Dose esclation part |
| Cohort C-1 | Experimental | Drug: TXN10128, Drug: PaclitaxelCombination therapy with TXN10128 and Paclitaxel Dose esclation part |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects ≥19 years of age at the time of informed consent.
- Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (4 listed)
- Has leptomeningeal disease.
- Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
- Prior organ transplantation.
- Known positive human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| TXN10128TXN10128: Oral administration once daily everyday | Drug | Cohort A-1, Cohort B-1, Cohort C-1 |
| IrinotecanIntravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle | Drug | Cohort B-1 |
| PaclitaxelIV administration at 80 mg/m2 three times (Day 1, Day 8, and Day 15) at intervals of 1 week in one cycle (IV administration at 90 mg/m2 for patients with breast cancer) | Drug | Cohort C-1 |
Primary outcome
DLT
Time frame: Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period
A DLT is defined as any of the following AEs (graded using NCI CTCAE v5.0) whose relationship to TXN10128 cannot be ruled out.
Adverse events (AE)
Time frame: Up to 30 days from end of treatment
Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level
11 secondary outcomes
Cmax
Time frame: Up to 21 days from Day 1 dose
AUC inf
Time frame: Up to 21 days from Day 1 dose
AUC last
Time frame: Up to 21 days from Day 1 dose
Tmax
Time frame: Up to 21 days from Day 1 dose
T1/2
Time frame: Up to 21 days from Day 1 dose
Vss
Time frame: Up to 21 days from Day 1 dose
Best overall response (BOR)
Time frame: Up to 30 days from end of treatment
Progression free survival (PFS)
Time frame: Up to 30 days from end of treatment
Disease control rate (DCR)
Time frame: Up to 30 days from end of treatment
Duration of Response (DOR)
Time frame: Up to 30 days from end of treatment
Overall response rate (ORR)
Time frame: Up to 30 days from end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Homepage of Txinno BioscienceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Min-Hee Ryu, M.D., Ph.D. principal investigator
Asan Medical Center
Do-Youn Oh, M.D., Ph.D. principal investigator
Seoul National University Hospital
Jin Seok Ahn, M.D., Ph.D. principal investigator
Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TXN10128, Irinotecan and Paclitaxel in people with Locally Advanced (Unresectable) or Metastatic Solid Tumors, run by Txinno Bioscience Inc. at 6 sites 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: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eun-Young Kwak, Ph.D. (82 31 778 8688, bella@txinno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Day 1 up to Day 21 for Cohort A(TXN10128 mono cohort) and Day 1 up to Day 28 for Cohort B,C(TXN10128 combination with Irinotecan or paclitaxel cohort) in dose escalation period). The study lists 2 primary outcomes in all. 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 24 Apr 2025.