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Original Article | Open Access

Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer

Ming Bai1,*, Yao Lu1,*, Chunmei Shi2, Jianwei Yang3, Wei Li4, Xianli Yin5, Chenghui Huang6, Lin Shen7, Liangzhi Xie8, Yi Ba1,9 ( )
Department of GI Medical Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, Tianjin 300060, China
Fujian Medical University Union Hospital, Fuzhou 350001, China
Fujian Provincial Cancer Hospital, Fuzhou 350014, China
Cancer Center, The First Hospital of Jilin University, Changchun 130021, China
Department of Medical Oncology Gastroenterology and Urology, Hunan Cancer Hospital, Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China
Department of Oncology, The Third Xiangya Hospital, Central South University, Changsha 410013, China
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China
Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China
Department of Cancer Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100010, China

*These authors contributed equally to this work.

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Abstract

Objective

This study evaluated the safety and efficacy of an anti-epidermal growth factor receptor (EGFR) antibody (SCT200) and an anti-programmed cell death 1 (PD-1) antibody (SCT-I10A) as third-line or subsequent therapies in patients with rat sarcoma viral oncogene (RAS)/v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (wt) metastatic colorectal cancer (mCRC).

Methods

We conducted a multicenter, open-label, phase Ib clinical trial. Patients with histologically confirmed RAS/BRAF wt mCRC with more than two lines of treatment were enrolled and treated with SCT-I10A and SCT200. The primary endpoints were the objective response rate (ORR) and safety. The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

Results

Twenty-one patients were enrolled in the study through January 28, 2023. The ORR was 28.57% and the DCR was 85.71% (18/21). The median PFS and OS were 4.14 and 12.84 months, respectively. The treatment-related adverse events (TRAEs) were tolerable. Moreover, compared with the monotherapy cohort from our previous phase Ⅰ study evaluating SCT200 for RAS/BRAF wt mCRC in a third-line setting, no significant improvements in PFS and OS were observed in the combination group.

Conclusions

SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt mCRC patients with an acceptable safety profile. Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting. (Registration No. NCT04229537).

Keywords

Colorectal cancerSCT-I10ASCT200epidermal growth factor receptorprogrammed cell death 1

Electronic Supplementary Material

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Cancer Biology & Medicine
Volume 21 Issue 7,
July 2024
Pages 636-650
DOI: 10.20892/j.issn.2095-3941.2023.0301
Cite this article:
Bai M, Lu Y, Shi C, et al. Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer. Cancer Biology & Medicine, 2024, 21(7): 636-650. https://doi.org/10.20892/j.issn.2095-3941.2023.0301

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Received: 15 August 2018
Accepted: 22 November 2023
Published: 25 July 2024
©2024 The Authors.

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