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Article History

Received: 24 June 2024

Accepted: 25 July 2024

First Online: 15 August 2024

Declarations

:

: The study will be approved by the appropriate institutional review board or ethic committee of participating clinical sites and will follow the principles of the Declaration of Helsinki for all human experimental investigations. Informed consent will be obtained from all the participating patients.

: The trial is registered at <i>clinicaltrials.gov</i>. The registration number is NCT06468033.

: Not applicable.

: G Abu-Zeinah: no competing interests to declare; A Qin: Currently working for PharmaEssentia and serving as the company’s chief medical officer; H Gill: Consulting fees/Speaker fees from Abbvie, Bristol Myers Squibb, GSK, MSD, Novartis, PharmaEssentia Corporation and Pfizer, Advisory board for Abbvie, Bristol Myers Squibb, GSK, Novartis, PharmaEssentia Corporation and Pfizer, Research support from Celgene, MSD, Novartis and PharmaEssentia Corporation, Conference support from Bristol Myers Squibb, MSD, Novartis, Otsuka, PharmaEssentia and Pfizer; N Komatsu: Served as a board member of and received funding for medical writing and article processing charges from PharmaEssentia Japan K.K. and received research funding from Meiji Seika Pharma Co., Ltd. and consulting fees from Torii Pharmaceutical Co., Ltd.; J Mascarenhas: Research support provided to the institution from Incyte, Novartis, Merck, CTI Bio, Roche, Kartos, Abbvie, Geron, BMS, and PharmaEssentia, Consulting fees from Incyte, Novartis, Roche, CTI Bio, Morphosys, BMS, Galecto, Karyopharm, Kartos, Abbvie, Sierra Onc, GSK, and PharmaEssentia; W Shih: Serving as a consultant of PharmaEssentia; O Zagrijtschuk is employed by PharmaEssentia USA; T Sato is employed by PharmaEssentia Japan K.K.; K Shimoda is a consultant for Sierra Oncology, Inc. and reports research funding from AbbVie G.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Kyowa Kirin Co., Ltd., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Otsuka Pharmaceutical Co., Ltd., PharmaEssentia Japan K.K., Shionogi & Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd.and honoraria from Takeda Pharmaceutical Co., Ltd., and Novartis Pharma K.K.; and is a member of an advisory committee for AbbVie G.K.; RT Silver: no competing interests to declare; R Mesa: Consultant (Honoraria) over past 3 years: Abbvie, Blueprint, BMS, CTI, Genentech, Geron, GSK, Incyte, Novartis, Sierra, Sierra Oncology, Telios; Research Support: Abbvie, Blueprint, BMS, CTI, Genentech, Incyte, Morphosys, Sierra.