{"id":2531,"date":"2025-11-04T15:31:26","date_gmt":"2025-11-04T15:31:26","guid":{"rendered":"https:\/\/www.lunit.io\/en\/?post_type=publication&p=2531"},"modified":"2025-11-17T15:35:17","modified_gmt":"2025-11-17T15:35:17","slug":"phase-1-study-of-imc-002-a-next-generation-anti-cd47-antibody-in-advanced-solid-tumors","status":"publish","type":"publication","link":"https:\/\/lunit.supremeclients.com\/ko\/publication\/phase-1-study-of-imc-002-a-next-generation-anti-cd47-antibody-in-advanced-solid-tumors\/","title":{"rendered":"Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors"},"content":{"rendered":"
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Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors<\/h3>\n<\/div>\n<\/div>\n
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<\/div>\n<\/div>\n

Jin Seok Ahn, Jung Yong Hong, Joon Oh Park, Sung Young Lee, SuYeon Kim, Hwi-yeol Yun, Chan-Young Ock, Woochan Hwang, Sung Ho Kim, Heung Tae Kim, Ho Yeong Lim<\/p>\n

Cancer Research and Treatment, 2025<\/strong><\/p>\n

Abstract<\/strong><\/p>\n

\n
Purpose<\/b>
\nIMC-002 is a fully human cluster of differentiation 47-targeted immunoglobulin G4 monoclonal antibody, designed to minimize off-target effects. This study (NCT05276310) assessed its safety\/tolerability and preliminary anti-tumor activity in patients with advanced solid tumors who were not eligible for or had progressed on standard treatment.
\nMaterials and Methods<\/b>
\nHere we report results from the initial 3 + 3 design dose-escalation part of a two-part Phase 1, open-label, dose-escalation\/expansion study. IMC-002 was administered intravenously every 2 weeks at four doses (5, 10, 20, and 30 mg\/kg). The primary objective was to assess safety\/tolerability, including maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Secondary objectives included pharmacokinetics and clinical activity, including best overall response (BOR), disease control rate (DCR), and clinical benefit rate (CBR).
\nResults<\/b>
\nTwelve patients were included in total, with three per dose level. Most patients (11\/12) had stage IV disease; 7\/12 had received three prior systemic therapies. No dose-limiting toxicities were observed and MTD was not reached. The most common treatment-related adverse events (TRAEs) were rash (9\/12), vitreous floaters (8\/12), and (hemolytic) anemia (5\/12). There was no treatment-related thrombocytopenia, neutropenia, or infection. IMC-002 had dose-proportional pharmacokinetics, achieving steady state levels from Cycle 2. BOR was stable disease in six patients (DCR 50.0%). CBR was 33% (four patients maintaining disease control for \u22656 months).
\nConclusion<\/b>
\nIMC-002 demonstrated favorable safety\/tolerability at doses of 5\u201330 mg\/kg every 2 weeks. RP2D was defined as 20 mg\/kg every 3 weeks. Preliminary anti-tumor activity was observed, with a CBR of 33%.<\/div>\n<\/div>\n

Read the full paper<\/b><\/a><\/p>\n","protected":false},"featured_media":0,"template":"","publication-oncology":[86,94],"publication-region":[87],"publication-type":[],"radiology":[],"class_list":["post-2531","publication","type-publication","status-publish","hentry","publication-oncology-others","publication-oncology-peer-reviewed-clinical-papers","publication-region-asia"],"acf":[],"yoast_head":"\nPhase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors - Lunit<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lunit.supremeclients.com\/publication\/phase-1-study-of-imc-002-a-next-generation-anti-cd47-antibody-in-advanced-solid-tumors\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors - 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