Evaluating TXN10128 for patients with solid tumors
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
Run by Txinno Bioscience Inc. · NCT05978492 · Data updated 2026-11-12
This study is testing a new treatment called TXN10128 to see if it's safe and effective for people with advanced solid tumors, both on its own and when combined with other cancer drugs.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Txinno Bioscience Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 6 sites (Seongnam-si, Gyeonggi-do and 5 other locations) |
| Status | Recruiting |
| Started | July 27, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | April 24, 2025 |
| Trial ID | NCT05978492 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 and older with progressive, locally advanced, or metastatic solid tumors that have not responded to standard therapies.
✕Probably not a fit
Patients with leptomeningeal disease or those who have experienced severe immune-related adverse events from prior immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I clinical trial aims to assess the safety and tolerability of TXN10128 in patients with locally advanced or metastatic solid tumors. The study includes a dose-escalation and dose-expansion design, evaluating TXN10128 both as a monotherapy and in combination with Irinotecan or Paclitaxel. Participants will be closely monitored for pharmacokinetics, pharmacodynamics, and antitumor activity throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.
How similar studies have gone: While this approach is novel, similar studies targeting solid tumors with investigational therapies have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea Recruiting -
Chungbuk National University Hospital
Cheonju, North Chungcheong, South Korea Recruiting -
Seoul National Univ. Hospital
Seoul, Seoul, South Korea Recruiting -
Asan Medical Center
Seoul, Seoul, South Korea Recruiting -
Gachon University Gil Medical Center
Incheon, South Korea Recruiting -
SAMSUNG Medical Center
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Min-Hee Ryu, M.D., Ph.D. — Asan Medical Center
- Study coordinator: Eun-Young Kwak, Ph.D.
- Email: bella@txinno.com
- Phone: 82 31 778 8688
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SG1906 treatment for certain solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.