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
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Purpose EMB-01 is a novel EGFR × c-MET 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). Patients and methods EMB-01 was administered at 1600 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. Results Fifty-two patients were enrolled (phase Ib, n=27; phase II, n=25). All patients (100%) experienced at least one treatment-emergent adverse event (TEAE), and 98.1% experienced treatment-related adverse events (TRAEs). Grade ≥ 3 TRAEs occurred in 63.5% of patients, with rash (25.0%) and dermatitis acneiform (17.3%) most frequently. Among the 48 mCRC patients, the confirmed objective response rate (cORR) was 12.5% (95% confidence interval [CI], 4.7 to 25.2%), with a median duration of response (DOR) of 32.0 weeks (95% CI, 16.0 to 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 to 43.5%) and 20.7% (95% CI, 8.0 to 39.7%), respectively. Median progression-free survival (mPFS) was 19.0 weeks (95% CI, 12.3 to 24.1 weeks). Conclusions 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.
Source: Clinical Cancer Research
Institutions: Peking University Cancer Hospital, The University of Texas MD Anderson Cancer Center, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Zhengzhou University, Gansu Provincial Hospital, Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital, Zhejiang University, Hunan Cancer Hospital, Shandong Tumor Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7204134150
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