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Peer-reviewedCC BY-NC-ND 4.0Clinical Cancer Research

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

  • Ting Xu1
  • Christine M. Parseghian2
  • Yanqiao Zhang3
  • Zhiyu Chen4
  • Yanru Qin5
  • Weisheng Zhang6
  • Yanhong Deng7
  • Hongming Pan8
  • Shanzhi Gu9
  • Changzheng Li10
  • Fang Ren11
  • Ying Wu11
6 more authors
  • Qiaoyang Lu11
  • Mingfei Zhang11
  • Rong Wang11
  • Yonghong Zhu11
  • Lin Shen1
  • Jian Li1
11 affiliations
  1. 1Peking University Cancer Hospital, Beijing, China.
  2. 2The University of Texas MD Anderson Cancer Center, Houston, Texas.
  3. 3Harbin Medical University Cancer Hospital, Harbin, China.
  4. 4Fudan University Shanghai Cancer Center, Shanghai, China.
  5. 5The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
  6. 6Gansu Provincial Hospital, Lanzhou, China.
  7. 7The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
  8. 8Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
  9. 9Hunan Cancer Hospital, Changsha, China.
  10. 10Shandong Cancer Hospital, Jinan, China.
  11. 11Shanghai EpimAb Biotherapeutics Co. Ltd., Shanghai, China.
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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).

Patients 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.

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, 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).

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.

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Cite

BibTeXRIS
BibTeX
@article{xu2026emb01,
  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}},
  author = {Ting Xu and Christine M. Parseghian and Yanqiao Zhang and Zhiyu Chen and Yanru Qin and Weisheng Zhang and Yanhong Deng and Hongming Pan and Shanzhi Gu and Changzheng Li and Fang Ren and Ying Wu and Qiaoyang Lu and Mingfei Zhang and Rong Wang and Yonghong Zhu and Lin Shen and Jian Li},
  journal = {Clinical Cancer Research},
  year = {2026},
  month = aug,
  doi = {10.1158/1078-0432.ccr-26-2128},
  url = {https://doi.org/10.1158/1078-0432.ccr-26-2128},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - 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
AU  - Ting Xu
AU  - Christine M. Parseghian
AU  - Yanqiao Zhang
AU  - Zhiyu Chen
AU  - Yanru Qin
AU  - Weisheng Zhang
AU  - Yanhong Deng
AU  - Hongming Pan
AU  - Shanzhi Gu
AU  - Changzheng Li
AU  - Fang Ren
AU  - Ying Wu
AU  - Qiaoyang Lu
AU  - Mingfei Zhang
AU  - Rong Wang
AU  - Yonghong Zhu
AU  - Lin Shen
AU  - Jian Li
PY  - 2026
DA  - 2026/08/24
JO  - Clinical Cancer Research
DO  - 10.1158/1078-0432.ccr-26-2128
UR  - https://doi.org/10.1158/1078-0432.ccr-26-2128
AB  - 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).  Patients 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.  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, 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).  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.
SN  - 1078-0432
SN  - 1557-3265
ER  -