{ "abstract": "Purpose:: EMB-01 is a novel epidermal growth factor receptor × mesenchymal–epithelial transition factor bispecific antibody. The phase Ib/II study (NCT05176665) presents the safety and antitumor activity of EMB-01 in patients predominantly with heavily pretreated metastatic colorectal cancer (mCRC).\n\nPatients and Methods:: EMB-01 was administered at 1,600 mg intravenously weekly. Primary endpoints were safety and tolerability in phase Ib and antitumor activity in phase II. Secondary endpoints included cross-phase validation of antitumor activity and safety. Exploratory endpoints included biomarker analysis.\n\nResults:: Fifty-two patients were enrolled (phase Ib, n = 27; phase II, n = 25). All patients (100%) experienced at least one treatment-emergent adverse event, and 98.1% experienced treatment-related adverse events (TRAE). Grade ≥3 TRAEs occurred in 63.5% of patients, with rash (25%) and dermatitis acneiform (17.3%) most frequently. Among the 48 patients with mCRC, the confirmed objective response rate (cORR) was 12.5% [95% confidence interval (CI), 4.7%–25.2%], with a median duration of response of 32 weeks (95% CI, 16–not estimable). All responses were observed in a favorable mCRC subgroup with evaluable response [left-sided, RAS/RAF wild-type, naïve to fruquintinib/regorafenib/trifluridine–tipiracil (TAS-102); n = 29]. In this subgroup, the unconfirmed ORR (uORR) and the cORR were 24.1% (95% CI, 10.3%–43.5%) and 20.7% (95% CI, 8%–39.7%), respectively. Median progression-free survival was 19 weeks (95% CI, 12.3–24.1 weeks).\n\nConclusions:: EMB-01 demonstrated a manageable safety profile and promising antitumor activity in heavily pretreated mCRC, particularly in the RAS/RAF wild-type, left-sided mCRC subgroup naïve to late-line therapies, warranting further clinical development.", "abstract_shown": true, "affiliations": [ "Peking University Cancer Hospital, Beijing, China.", "The University of Texas MD Anderson Cancer Center, Houston, Texas.", "Harbin Medical University Cancer Hospital, Harbin, China.", "Fudan University Shanghai Cancer Center, Shanghai, China.", "The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.", "Gansu Provincial Hospital, Lanzhou, China.", "The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.", "Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.", "Hunan Cancer Hospital, Changsha, China.", "Shandong Cancer Hospital, Jinan, China.", "Shanghai EpimAb Biotherapeutics Co. Ltd., Shanghai, China." ], "article_type": "research article", "arxiv": null, "author_total": 18, "authors": [ { "affs": [ 0 ], "name": "Ting Xu", "orcid": "0000-0002-1381-1609" }, { "affs": [ 1 ], "name": "Christine M. Parseghian", "orcid": "0000-0002-2047-097X" }, { "affs": [ 2 ], "name": "Yanqiao Zhang", "orcid": "0000-0002-6206-8364" }, { "affs": [ 3 ], "name": "Zhiyu Chen", "orcid": "0000-0002-5988-6294" }, { "affs": [ 4 ], "name": "Yanru Qin", "orcid": "0000-0003-2175-9617" }, { "affs": [ 5 ], "name": "Weisheng Zhang", "orcid": "0009-0008-5836-1155" }, { "affs": [ 6 ], "name": "Yanhong Deng", "orcid": "0000-0001-6873-8026" }, { "affs": [ 7 ], "name": "Hongming Pan", "orcid": "0000-0001-5034-3392" }, { "affs": [ 8 ], "name": "Shanzhi Gu", "orcid": "0009-0008-8937-4047" }, { "affs": [ 9 ], "name": "Changzheng Li", "orcid": "0009-0005-0778-4543" }, { "affs": [ 10 ], "name": "Fang Ren", "orcid": "0009-0002-4864-9354" }, { "affs": [ 10 ], "name": "Ying Wu", "orcid": "0009-0007-6254-5291" }, { "affs": [ 10 ], "name": "Qiaoyang Lu", "orcid": "0009-0002-1720-9946" }, { "affs": [ 10 ], "name": "Mingfei Zhang", "orcid": "0009-0000-9632-578X" }, { "affs": [ 10 ], "name": "Rong Wang", "orcid": "0000-0001-8797-2459" }, { "affs": [ 10 ], "name": "Yonghong Zhu", "orcid": "0009-0000-0858-1506" }, { "affs": [ 0 ], "name": "Lin Shen", "orcid": "0000-0003-1134-2922" }, { "affs": [ 0 ], "name": "Jian Li", "orcid": "0000-0002-9333-3255" } ], "bibtex": "https://research.draconitic.com/paper/6mgccqh87xm00.bib", "cited_by": 0, "doi": "10.1158/1078-0432.ccr-26-2128", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13725330/", "id": "6mgccqh87xm00", "issns": [ "1078-0432", "1557-3265" ], "landing_url": "https://doi.org/10.1158/1078-0432.ccr-26-2128", "language": "en", "licence": "CC-BY-NC-ND-4.0", "licence_label": "CC BY-NC-ND 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "Biological Agents & Therapies" ], [ "heading", "Bispecific Antibodies" ], [ "heading", "Clinical Trial Results" ], [ "heading", "Clinical Trials: Antibody-Based Therapy" ], [ "heading", "Colorectal Cancer" ], [ "heading", "Gastrointestinal Cancers" ], [ "openalex", "2730|Colorectal Cancer Treatments and Studies" ] ], "openalex": "W7204134150", "pdf_url": null, "pmcid": "PMC13725330", "pmid": "42635595", "published": "2026-08-24", "publisher": null, "ris": "https://research.draconitic.com/paper/6mgccqh87xm00.ris", "sources": [ { "first_seen": "2026-11-04T12:23:45Z", "native_id": "PMC13725330", "source": "pmc", "url": "https://doi.org/10.1158/1078-0432.ccr-26-2128" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2730|Colorectal Cancer Treatments and Studies", "subfield": "oncology" } ], "title": "EMB-01, an Anti-EGFR/c-MET Bispecific Antibody, in Patients with Heavily Pretreated Metastatic Colorectal Cancer from a Phase Ib/II, Open-Label, Multicenter Study", "title_text": "EMB-01, an Anti-EGFR/c-MET Bispecific Antibody, in Patients with Heavily Pretreated Metastatic Colorectal Cancer from a Phase Ib/II, Open-Label, Multicenter Study", "type": "peer-reviewed", "updated_at": "2026-11-06T12:21:37Z", "url": "https://research.draconitic.com/paper/6mgccqh87xm00", "venue": "Clinical Cancer Research", "versions": [] }