drugset / Trial / NCT05978492
A Study of TXN10128 in Subjects With Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-27
- Primary completion
- 2025-12-31
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 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) | Unknown | 80 mg/m2 | Intravenous |
| Subject | 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) | Unknown | 90 mg/m2 | Intravenous |
| Subject | Intravenous (IV) administration at 150 mg/m2 twice (Day 1 and Day 15) at intervals of 2 weeks in one cycle | Unknown | 150 mg/m2 | Intravenous |
| Subject | TXN10128 | Unknown | — | Oral |