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
Txinno Bioscience Inc.
96 participants
Jul 27, 2023
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
TXN10128: Oral administration once daily everyday
Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle
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)
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05978492