drugset / Trial / NCT06205082
A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets. This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).
Timeline
- Start
- 2023-10-14
- Primary completion
- 2025-10-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LIT-00814 | Unknown | 20 mg | Oral |
| Subject | LIT-00814 | Unknown | 50 mg | Oral |
| Subject | LIT-00814 | Unknown | 100 mg | Oral |
| Subject | LIT-00814 | Unknown | 150 mg | Oral |