Evaluating TXN10128 for patients with solid tumors
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
PHASE1 · Txinno Bioscience Inc. · NCT05978492
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Txinno Bioscience Inc. (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 6 sites (Seongnam-si, Gyeonggi-do and 5 other locations) |
| Trial ID | NCT05978492 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is novel, similar studies targeting solid tumors with investigational therapies have shown promise in the past.
Eligibility criteria
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 this trial is running
Seongnam-si, Gyeonggi-do and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced or Metastatic Solid Tumors, ENPP1, ENPP1 inhibitor, TXN10128, TxinnoBio, Txinno Bioscience, Innate immune, STING pathway