CPGJ602 plus mFOLFOX6 as first-line treatment for patients with KRAS/NRAS/BRAF wild-type metastatic colorectal cancer: A randomized phase II study.

• DOI: 10.1200/jco.2022.40.16_suppl.3574
• Publication Date: 2022-06-06T16:13:21Z
• Authors: Jianming Xu; Bangwei Cao; Kangsheng Gu; Yuxian Bai; Wei Li; Jingdong Zhang; Caigang Liu; Zuoxing Niu; Liangming Zhang; Haijun Zhong; SuXia Luo; Jian-Wei Zhou; Tianshu Liu; Yanhong Gu; Jingguan Lin; Yanhong Deng; Chuangqi Chen; Yunfeng Li; Xiuli Yang; Bihui Li
• Keywords: Clinical endpoint

3574 Background: CPGJ602 is a recombinant anti-EGFR human-mouse chimeric monoclonal antibody. plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) may have efficacy in KRAS/NRAS/BRAF wild-type metastatic colorectal cancer. Methods: In this open-label, randomized trial, patients who had received no previous treatment were randomly assigned (2:2:1) to receive CPGJ60（325mg/m 2 , q2w) mFOLFOX6 (biweekly group), (400 mg/m initial dose followed by 250 /week thereafter) (weekly group) or cetuximab (cetuximab group). All subjects up 16 weeks. The primary endpoint was the best overall response (BOR) at second endpoints DCR, DOR, PFS, safety. Results: As of Dec 30, 2021, 76 enrolled (30 biweekly group, 32 weekly group 14 control achieved weeks 76.7% (23/30, 95% CI 60.3% - 92.0%),78.1% (25/32, 62.5% 92.5%) 78.6% (11/14, 49.2% 95.3%) respectively. confirmed rate 60%(18/30), 71.9%(23/32) 57.1%(8/14) PFS rates 81.5% (95% 57.7% -92.6%), 96.8% 79.2%-99.5%), 81.3% 41.5%- 95.2%) most common adverse events decreased neutrophil count (60%，78.1% 71.4% respectively), white-cell (53.3%, 78.1% platelet (40.0%, 40.6% 42.9% elevated serum aspartate aminotransferase (43.3%, 37.5% 35.7% respectively). Conclusions: could be an option for Clinical trial information: NCT04466254.