A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours

Advanced or Metastatic Solid Tumours Clinical Trial

Official title: A Phase I Open and Multiple Ascending Dose Study to Assess the Safety、Tolerability、Pharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumours
• Neoplasms

• NCT number: NCT03658070
• Study type: Interventional
• Source: Shijiazhuang Yiling Pharmaceutical Co. Ltd
• Contact: wei wang, master
• Phone: 086-0311-66703017
• Email: wangwei001@yiling.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: December 19, 2018
• Completion date: December 2020