Clinical trial · Interventional
A Study of TXN10128 in Subjects 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced (Unresectable) or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| TXN10128 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A-1
- description
- TXN10128 Monotherapy Dose esclation part
- interventionNames
- Drug: TXN10128
- type
- EXPERIMENTAL
- label
- Cohort B-1
- description
- Combination Therapy with TXN10128 and Irinotecan Dose esclation part
- interventionNames
- Drug: TXN10128
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Cohort C-1
- description
- Combination therapy with TXN10128 and Paclitaxel Dose esclation part
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available