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A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer

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dc.contributor.authorLee, Keun-Wook-
dc.contributor.authorHan, Sae-Won-
dc.contributor.authorKim, Tae Won-
dc.contributor.authorAhn, Joong Bae-
dc.contributor.authorBaek, Ji Yeon-
dc.contributor.authorCho, Sang Hee-
dc.contributor.authorLee, Howard-
dc.contributor.authorKim, Jin Won-
dc.contributor.authorKim, Ji-Won-
dc.contributor.authorKim, Tae-You-
dc.contributor.authorHong, Yong Sang-
dc.contributor.authorBeom, Seung-Hoon-
dc.contributor.authorCha, Yongjun-
dc.contributor.authorChoi, Yoonjung-
dc.contributor.authorKim, Seonhui-
dc.contributor.authorBang, Yung-Jue-
dc.date.accessioned2024-06-04T04:27:48Z-
dc.date.available2024-06-04T04:27:48Z-
dc.date.created2024-05-31-
dc.date.created2024-05-31-
dc.date.issued2024-04-
dc.identifier.citationCancer Research and Treatment, Vol.56 No.2, pp.590-601-
dc.identifier.issn1598-2998-
dc.identifier.urihttps://hdl.handle.net/10371/204216-
dc.description.abstractPurpose GC1118 is a novel antibody targeting epidermal growth factor receptor (EGFR) with enhanced blocking activity against both low- and high-affinity EGFR ligands. A phase 1b/2a study was conducted to determine a recommended phase 2 dose (RP2D) of GC1118 in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) (phase 1b) and to assess the safety and efficacy of GC1118 plus FOLFIRI as a second-line therapy for recurrent/metastatic colorectal cancer (CRC) (phase 2a). Materials and Methods Phase 1b was designed as a standard 3+3 dose-escalation study with a starting dose of GC1118 (3 mg/ kg/wk) in combination with biweekly FOLFIRI (irinotecan 180 mg/m2; leucovorin 400 mg/m2; 5-fluorouracil 400 mg/m2 bolus and 2,400 mg/m2 infusion over 46 hours) in patients with solid tumors refractory to standard treatments. The subsequent phase 2a part was conducted with objective response rate (ORR) as a primary endpoint. Patients with KRAS/NRAS/BRAF wild-type, EGFR-positive, recurrent/metastatic CRC resistant to the first-line treatment were enrolled in the phase 2a study. Results RP2D of GC1118 was determined to be 3 mg/kg/wk in the phase 1b study (n=7). Common adverse drug reactions (ADRs) observed in the phase 2a study (n=24) were acneiform rash (95.8%), dry skin (66.7%), paronychia (58.3%), and stomatitis (50.0%). The most common ADR of >= grade 3 was neutropenia (33.3%). ORR was 42.5% (95% confidence interval [CI], 23.5 to 62.0), and median progression-free survival was 6.7 months (95% CI, 4.0 to 8.0). Conclusion GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.-
dc.language영어-
dc.publisher대한암학회-
dc.titleA Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer-
dc.typeArticle-
dc.identifier.doi10.4143/crt.2023.1117-
dc.citation.journaltitleCancer Research and Treatment-
dc.identifier.wosid001208949300032-
dc.identifier.scopusid2-s2.0-85190355603-
dc.citation.endpage601-
dc.citation.number2-
dc.citation.startpage590-
dc.citation.volume56-
dc.identifier.kciidART003070667-
dc.description.isOpenAccessY-
dc.contributor.affiliatedAuthorLee, Keun-Wook-
dc.contributor.affiliatedAuthorLee, Howard-
dc.contributor.affiliatedAuthorKim, Ji-Won-
dc.contributor.affiliatedAuthorKim, Tae-You-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlus2ND-LINE TREATMENT-
dc.subject.keywordPlusEGFR-
dc.subject.keywordPlusPANITUMUMAB-
dc.subject.keywordAuthorGC1118-
dc.subject.keywordAuthorColorectal neoplasms-
dc.subject.keywordAuthorErbB receptors-
dc.subject.keywordAuthorMonoclonal antibody-
dc.subject.keywordAuthorIrinotecan-
dc.subject.keywordAuthorFOLFIRI-
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  • Department of Medicine
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