drugset / Trial / NCT04088604
Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of LY01610 monotherapy and combine with 5-Fu in patients with advanced solid tumors. Additionally, the pharmacokinetics and preliminary efficacy of LY01610 monotherapy and combine with 5-Fu will be investigated in this study.
Timeline
- Start
- 2019-02-15
- Primary completion
- 2021-12-17
- Completion
- 2021-12-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | LY01610 | Unknown | 30 mg/m2 | Intravenous |
| Subject | LY01610 | Unknown | 60 mg/m2 | Intravenous |
| Subject | LY01610 | Unknown | 90 mg/m2 | Intravenous |
| Subject | LY01610 | Unknown | 120 mg/m2 | Intravenous |
| Subject | LY01610 | Unknown | 150 mg/m2 | Intravenous |
| Subject | LY01610 | Unknown | 180 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |