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NCT Number: NCT05978492

A Study of TXN10128 in Subjects With 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.

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Key information

Conditions

Locally Advanced (Unresectable) or Metastatic Solid Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

TXN10128

Drug

TXN10128: Oral administration once daily everyday

Irinotecan

Drug

Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle

paclitaxel

Drug

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)

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Cmax

    Time frame: Up to 21 days from Day 1 dose

    The time to reach the maximum observed concentration (time)

  2. AUC inf

    Time frame: Up to 21 days from Day 1 dose

    The area under the concentration-time curve extrapolated to infinity (mass*time/volume)

  3. AUC last

    Time frame: Up to 21 days from Day 1 dose

    The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass* time/volume)

  4. Tmax

    Time frame: Up to 21 days from Day 1 dose

    The time to reach the maximum observed concentration (time)

  5. T1/2

    Time frame: Up to 21 days from Day 1 dose

    Elimination half-life, determined as 0.693/Lambda_z (time)

  6. Vss

    Time frame: Up to 21 days from Day 1 dose

    Volume of distribution during the steady state phase (volume)

  7. Best overall response (BOR)

    Time frame: Up to 30 days from end of treatment

    Best overall response will be summarized

  8. Progression free survival (PFS)

    Time frame: Up to 30 days from end of treatment

    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.

  9. Disease control rate (DCR)

    Time frame: Up to 30 days from end of treatment

    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

  10. Duration of Response (DOR)

    Time frame: Up to 30 days from end of treatment

    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

  11. Overall response rate (ORR)

    Time frame: Up to 30 days from end of treatment

    Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).

Study contacts

Contact information is provided by the study sponsor or research team.

Eun-Young Kwak, Ph.D.

CONTACT

[email protected]

82 31 778 8688

Sponsors and collaborators

Lead sponsor

Txinno Bioscience Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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