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Original Article
- Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors
- 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
- Received August 4, 2025 Accepted November 3, 2025 Published online November 4, 2025
- DOI: https://doi.org/10.4143/crt.2025.820 [Epub ahead of print]
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Abstract
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Supplementary Material
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ePub - Purpose
IMC-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.
Materials and Methods
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).
Results
Twelve 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 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 ≥ 6 months).
Conclusion
IMC-002 demonstrated favorable safety/tolerability at doses of 5-30 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%. -
Citations
Citations to this article as recorded by
- The CD47 signaling axis regulates the formation and vulnerability of atherosclerotic plaques: mechanism analysis and targeting strategies
Liyang Bai, Baofeng Xu, Ying Chen, Dan Fu, Lijuan Wang, Di Ma
Frontiers in Immunology.2026;[Epub] CrossRef - Pretransfusion testing interference profile of IMC‐002: A novel anti‐CD47 monoclonal antibody engineered for minimized red cell binding
Tae‐Shin Kim, Jae Hyeon Park, Yousun Chung, Dae‐Hyun Ko, Seon Young Kim, Hyungsuk Kim
Transfusion.2026;[Epub] CrossRef
- The CD47 signaling axis regulates the formation and vulnerability of atherosclerotic plaques: mechanism analysis and targeting strategies
- 1,994 View
- 136 Download
- 2 Crossref
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