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Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies
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CX1003 quantification by ultra-performance LC-MS/MS in human plasma and its application to a pharmacokinetic study in
Yu Li1,2, Qian Zhao1,2, Pei Hu1,2
1Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100032, PR China.
Abstract:
Aim: CX1003 is a novel multitargeted receptor tyrosine kinase inhibitor targeting cancer patients with relapsed or metastatic malignant solid tumors. The study aimed to develop a robust and rapid assay approach to quantify CX1003 in human plasma. Methodology & results: Samples of plasma were purified by SPE where the diluted eluates were then separated by a Waters Acquity CSH C18 column and thereafter detected using positive electrospray ionization via an ultra performance LC-MS/MS. Conclusion: The method to quantify CX1003 in human plasma was first exploited and validated with good sensitivity and specificity, and successfully fulfilled the requirement of the first-in-human clinical pharmacokinetic study of CX1003 in Chinese patients with relapsed or metastatic malignant solid tumors.
Insights
A new assay quantifies CX1003, a novel cancer drug, in human plasma. This validated method supports early clinical trials for patients with advanced solid tumors.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Oncology
Background:
- CX1003 is a novel multitargeted receptor tyrosine kinase inhibitor.
- It is intended for patients with relapsed or metastatic malignant solid tumors.
Purpose of the Study:
- To develop a robust and rapid assay for quantifying CX1003 in human plasma.
- To validate the assay for use in clinical pharmacokinetic studies.
Main Methods:
- Plasma samples were purified using solid-phase extraction (SPE).
- Separation was performed on a Waters Acquity CSH C18 column.
- Detection utilized positive electrospray ionization via ultra-performance LC-MS/MS.
Main Results:
- The developed assay demonstrated good sensitivity and specificity.
- The method was successfully validated for quantifying CX1003 in human plasma.
Conclusions:
- The validated assay is suitable for quantifying CX1003 in human plasma.
- This method supports the first-in-human clinical pharmacokinetic study of CX1003 in Chinese patients.
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