A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours
Summary
1. To observe the safety and tolerability of oral XY0206 in patients with advanced/metastatic malignant solid tumor in China, and observe the drug dose limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) in humans. 2. To investigate the pharmacokinetic (PK) characteristics, pharmacodynamics (PD) characteristics, and PK/PD correlation of single and multiple doses of XY0206 in patients with advanced/metastatic malignant solid tumors to provide dose selection basis for clinical studies; 3. To evaluate the effect of standard meal on main PK parameters of XY0206; 4. To determine the metabolites of XY0206 in patients with advanced/metastatic malignant solid tumor. 5. To explore the correlation between PK and QTcF. 6. Preliminary investigates the effectiveness of XY0206 in patients with advanced/metastatic malignant solid tumors.
Timeline
- Start
- 2018-12-19
- Primary completion
- 2020-12
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XY0206 | Unknown | 12.5 mg | Oral |
| Subject | XY0206 | Unknown | 25 mg | Oral |
| Subject | XY0206 | Unknown | 37.5 mg | Oral |
| Subject | XY0206 | Unknown | 50 mg | Oral |
| Subject | XY0206 | Unknown | 75 mg | Oral |
| Subject | XY0206 | Unknown | 100 mg | Oral |
Indications
No indication recorded.