Research Article

Development and validation of a high performance liquid chromatography–MS/MS method for determination of SOMCL-15-290 in a first-in-human study

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

State Key Laboratory of Complex Severe & Rare Diseases, NMPA Key Laboratory for Clinical Research & Evaluation of Drug, Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Beijing, 100730, China

‡These authors contributed equally to this work

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Fan Zhang‡

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

‡These authors contributed equally to this work

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Aijing Liu

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

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Mengyang Yu

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

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Hongyun Wang

*Author for correspondence: Tel.: +86 10 6915 4637;

E-mail Address: wanghy@pumch.cn

https://orcid.org/0000-0002-8852-6490

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China

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Published Online:20 May 2022https://doi.org/10.4155/bio-2022-0014

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Abstract

Background: SOMCL-15-290 is a novel inhibitor that targets FGF receptor, CSF1 receptor and VEGF receptor (kinase insert domain receptor). Aim: This study was aiming at developing a specific high performance liquid chromatography–MS/MS method for quantifying SOMCL-15-290 in human plasma and supporting the first-in-human study. Methods: Plasma samples were prepared using the protein precipitation method and separated on a C18 110A column with acetonitrile and 0.2% formic acid solution as mobile phases. Quantification of SOMCL-15-290 was operated on an Xevo-TQS triple quadrupole tandem mass spectrometer in electrospray ionization positive mode. Results & conclusion: The validated determination method of SOMCL-15-290 has proved feasible and was successfully utilized in the first-in-human study of SOMCL-15-290 in advanced solid tumor patients.

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Vol. 14, No. 10

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History

Received 25 January 2022

Accepted 9 May 2022

Published online 20 May 2022

Published in print May 2022

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Financial & competing interests disclosure

This study was supported by the National Key R&D Program of China (2020YFC2008303) and Shanghai Runshi Pharmaceutical Technology Co. Ltd (Shanghai, China). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

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