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9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study

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资源类型：
Pubmed体系：
作者：
Zhang J[1,2,3] * ; Liu R[1,2,3] * ; Wang S[4] * ; Feng Z[4] * ; Yang H[5] ; Gao S[1,2,3] ; Li X[6] ; Yao X[7] ; Chen J[8] ; Gong Z[8] ; Li Y[9] ; Li X[10] ; Wang S[11] ; Hu C[12] ; Liu J[13] ; Zhang M[14] ; Yuan F[15] ; Shi B[16] ; Lou H[17] ; Zhao P[18] ; Qiu F[19] ; Guo H[20] ; Hu B[21] ; Xu D[22] ; Huang H[23] ; Zhang X[24] ; Feng M[25] ; Wang X[26] ; Li G[27] ; Liu D[4] ; Chen X[4] ; Wang P[4] ;
机构： [1]Phase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China [2]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [3]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China [4]Mabwell (Shanghai) Bioscience Co., Ltd., Shanghai, China [5]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [6]Oncology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [7]Urologic Oncology Department, Tianjin Medical University Cancer Hospital,Tianjin, China [8]Department of Medical Oncology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, China [9]Department of Oncology, Shenyang Chest Hospital, Shenyang, China [10]Gynecologic Oncology Department, Linyi Cancer Hospital, Linyi, China [11]Department of Oncology, The Second People's Hospital of Yibin City, Yibin, China [12]Department of Oncology, Anhui Provincial Cancer Hospital, Hefei, China [13]Department of Biotherapy, Cancer Center, West China Hospital of Sichuan University, Chengdu, China [14]Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China [15]Department of Urologic Oncology Surgery, Chongqing University Cancer Hospital, Chongqing, China [16]Department of Urology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China [17]Gynecologic Radiation Department, Zhejiang Cancer Hospital, Hangzhou, China [18]Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [19]Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [20]Urology Department, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China [21]Department of Urology, Liaoning Cancer Hospital and Institute, Shenyang, China [22]Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China [23]Department of Urinary Surgery, The First Affiliated Hospital of WenzhouMedical University, Wenzhou, China [24]Department of Urology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [25]Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China [26]Department of Oncology, The Second People’s Hospital of Neijiang, Neijiang, China [27]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
出处：
DOI： 10.1016/j.annonc.2025.04.009
ISSN：

关键词： Nectin-4 9MW2821 solid tumors

摘要：
A first-in-human study was performed to assess the safety and preliminary antitumor activity of 9MW2821, a next-generation monoclonal antibody-drug conjugate (ADC) that delivers monomethylauristatin E (MMAE) to cells expressing Nectin-4, in patients with advanced solid tumors.This is a first-in-human, open label, multicenter study included dose escalation, dose expansion and cohort expansion periods. Patients with advanced solid tumors who failed ≥1 line of systemic therapy were recruited to receive 9MW2821 by intravenous (IV) infusion at doses of 0.33-1.5mg/kg on days 1,8 and 15 of each 28-day cycle. Primary objective were assessment of safety and preliminary efficacy. (NCT05216965, CTR20220106) RESULTS: Between June 11, 2022, and Apr 3, 2024, 274 patients were enrolled, including 51 with urothelial cancer, 62 with cervical cancer, 49 with esophageal cancer, 20 with triple negative breast cancer and 92 with other solid tumors. In dose escalation phase, one dose limiting toxicity was observed in 1.5mg/kg group, which was grade 4 neutropenia lasted more than 5 days. Maximum tolerated dose of 9MW2821 was not reached. However, the recommended phase Ⅱ dose was identified as 1.25mg/kg based on balance of safety and efficacy. The most common ≥Grade 3 treatment related adverse events were neutrophil count decreased, white blood cell (WBC) count decreased, anemia, gamma-glutamyl transferase (GGT) increased rash and peripheral sensory neuropathy in 1.25mg/kg group. Among 226 patients evaluable for efficacy, objective response rates were 54.1%, 32.1%, 14.0% and 50% in urothelial cancer, cervical cancer, esophageal cancer and triple negative breast cancer, respectively.The results suggest that 9MW2821 was tolerable and clinically significant in efficacy in various types of solid tumors besides urothelial cancer. Several pivotal trials are currently in progress. (NCT06196736, NCT06592326, NCT06692166).Copyright © 2025 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

基金：
This work was supported by Mabwell (Shanghai) Bioscience Co., Ltd.. No grant number is applicable.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
第一作者：
第一作者机构： [1]Phase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China [2]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [3]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
共同第一作者：
通讯作者：
通讯机构： [1]Phase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China [2]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [3]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
推荐引用方式(GB/T 7714)：
Zhang J,Liu R,Wang S,et al.9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study[J].Annals Of Oncology : Official Journal Of The European Society For Medical Oncology.2025,doi:10.1016/j.annonc.2025.04.009.
APA：
Zhang J,Liu R,Wang S,Feng Z,Yang H...&Wang P.(2025).9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study.Annals Of Oncology : Official Journal Of The European Society For Medical Oncology,,
MLA：
Zhang J,et al."9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study".Annals Of Oncology : Official Journal Of The European Society For Medical Oncology .(2025)

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