Advanced or Metastatic Solid Tumours Clinical Trial
Official title:
A Phase I Open and Multiple Ascending Dose Study to Assess the SafetyćTolerabilityćPharmacokinetics and Pharmacodynamic Characteristics of XY0206 in Subjects With Chinese Advanced or Metastatic Solid Tumours
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.
n/a
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