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Article History

Received: 10 July 2025

Accepted: 23 July 2025

First Online: 25 August 2025

Declarations

:

: The scientific and ethical aspects of the study were reviewed and approved by the Institutional Review Board of each participating institution (IRB number for Seoul National University Hospital, the coordinating center: H-2202–028-1297), as well as the Protocol Review Committee of the KCSG, prior to patient enrollment. In addition, the Part 2 study protocol was reviewed and approved by the Ministry of Food and Drug Safety of Korea. Written informed consent for study participation was obtained separately for Part 1 and Part 2 by the investigators at each participating institution.

: Not applicable.

: YC reports a consulting or advisory role with IMBdx. SHC, EYP, DEL, and TP declare no competing interests. MKC reports a consulting or advisory role with Natera, Guardant Health, Celltrion, and Takeda. IGH declares no competing interests. SHB and BWK declare no competing interests. JSK reports a former advisory role with IMBdx. SYK (Sun Young Kim) reports institutional research funding from F. Hoffmann-La Roche Ltd and a consulting or advisory role with Roche Korea, AstraZeneca, Natera, and Merck Sharp & Dohme Korea. STK and SYK (Seok Yun Kang) declare no competing interests. JWK reports a consulting or advisory role with AstraZeneca, Ono Pharmaceutical, BeiGene, BeyondBio, Bristol Myers Squibb/Celgene, Eisai, GC Cell, MSD, Sanofi-Aventis, Celltrion, Natera, and Servier, and institutional research funding from Boryung and Samyang Biopharm. SWH reports a consulting or advisory role with AbbVie, AstraZeneca, Natera, Ono Pharmaceutical, Bayer, Cell Biotech, and BeyondBio, and institutional research funding from Boryung, IMBdx, Hanmi, Loxo, Roche, Genentech, Mirati Therapeutics, Turnstone Bio, Arcus Biosciences, MSD, BeyondBio, Jeil Pharmaceutical, Janssen, Seagen, Lilly, MedImmune, Leap Therapeutics, Hengrui Pharmaceutical, GC Pharma, AbbVie, Cell Biotech, Astellas, Merck, and AstraZeneca.