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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
DC Field | Value | Language |
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dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Han, Sae-Won | - |
dc.contributor.author | Kim, Tae Won | - |
dc.contributor.author | Ahn, Joong Bae | - |
dc.contributor.author | Baek, Ji Yeon | - |
dc.contributor.author | Cho, Sang Hee | - |
dc.contributor.author | Lee, Howard | - |
dc.contributor.author | Kim, Jin Won | - |
dc.contributor.author | Kim, Ji-Won | - |
dc.contributor.author | Kim, Tae-You | - |
dc.contributor.author | Hong, Yong Sang | - |
dc.contributor.author | Beom, Seung-Hoon | - |
dc.contributor.author | Cha, Yongjun | - |
dc.contributor.author | Choi, Yoonjung | - |
dc.contributor.author | Kim, Seonhui | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.date.accessioned | 2024-06-04T04:27:48Z | - |
dc.date.available | 2024-06-04T04:27:48Z | - |
dc.date.created | 2024-05-31 | - |
dc.date.created | 2024-05-31 | - |
dc.date.issued | 2024-04 | - |
dc.identifier.citation | Cancer Research and Treatment, Vol.56 No.2, pp.590-601 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://hdl.handle.net/10371/204216 | - |
dc.description.abstract | Purpose 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.language | 영어 | - |
dc.publisher | 대한암학회 | - |
dc.title | A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer | - |
dc.type | Article | - |
dc.identifier.doi | 10.4143/crt.2023.1117 | - |
dc.citation.journaltitle | Cancer Research and Treatment | - |
dc.identifier.wosid | 001208949300032 | - |
dc.identifier.scopusid | 2-s2.0-85190355603 | - |
dc.citation.endpage | 601 | - |
dc.citation.number | 2 | - |
dc.citation.startpage | 590 | - |
dc.citation.volume | 56 | - |
dc.identifier.kciid | ART003070667 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Lee, Keun-Wook | - |
dc.contributor.affiliatedAuthor | Lee, Howard | - |
dc.contributor.affiliatedAuthor | Kim, Ji-Won | - |
dc.contributor.affiliatedAuthor | Kim, Tae-You | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | 2ND-LINE TREATMENT | - |
dc.subject.keywordPlus | EGFR | - |
dc.subject.keywordPlus | PANITUMUMAB | - |
dc.subject.keywordAuthor | GC1118 | - |
dc.subject.keywordAuthor | Colorectal neoplasms | - |
dc.subject.keywordAuthor | ErbB receptors | - |
dc.subject.keywordAuthor | Monoclonal antibody | - |
dc.subject.keywordAuthor | Irinotecan | - |
dc.subject.keywordAuthor | FOLFIRI | - |
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