A multicenter, phase 1 study of AB011, a recombinant humanized anti-CLDN18.2 monoclonal antibody, as monotherapy and combined with capecitabine and oxaliplatin (CAPOX) in patients with advanced solid tumors.

• DOI: 10.1200/jco.2023.41.4_suppl.391
• Publication Date: 2023-01-24T21:05:07Z
• Authors: Jin Li; Hongming Pan; Tianshu Liu; Nong Xu; Yanqiao Zhang; Yanru Qin; Jianhua Shi; Dongcheng Liao; Lin Shen; Suxia Luo; Yueyin Pan; Wei Zhao; Yu Zheng; Rongyuan Zhuang; Chenyu Mao; Yue Ma; Huamao Wang; Zonghai Li
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

391 Background: Claudin18.2 (CLDN18.2) is normally confined in tight junction of the gastric mucosa, but also often expressed several cancer types. AB011 a humanized, anti-CLDN18.2 monoclonal antibody (IgG1), which has shown impressive therapeutic synergy between and cytotoxic agents preclinical research. Here we report preliminary data on both as monotherapy combined with CAPOX patients advanced solid tumors (AB011-ST-01, NCT04400383). Methods: The primary objectives were to evaluate safety efficacy (Part 1) plus chemotherapy 2) tumors. In part 1, CLDN18.2 positive, treatment-refractory cancer/gastroesophageal adenocarcinoma (GC/GEJA) pancreatic (PC) enrolled. dose levels from 1mg/kg 30mg/kg explored using i3 + 3 design dose-escalation stage, dose-expansion 20mg/kg further evaluated. 2, GC/GEJA eligible if they had measurable lesions positive expression (IHC 2+/3+ ≥ 40%). design. Data are reported Sep06, 2022. Results: [Part 1] From Aug 2020 2021, 14 pts treated at 3, 10, 20 21 stage (10 11 30mg/kg). 77.1% received 2 prior lines treatment. 12/26 (46.2%) GC/GEJ metastatic organs 15 (57.7%) peritoneal dissemination; 6/9 (66.7%) PC organs. Most treatment-related adverse events (TRAEs) grade 1-2. 8 experienced TRAEs (3 5 One DLT (grade dyspnea) occurred group. Among disease least one tumor assessment, control was observed 12pts, 1 GC (30mg/kg) without target assessed be CR. 2] September 2021 July 2022, 24 (13 20mg/kg, 45.8% ≥3 organs, 29.2% dissemination. TRAEs, incl. neutrophil count decreased, anemia, hypoalbuminemia, nausea vomiting. No DLT, or leading treatment discontinuation death. 23 who assessment by cut-off, 8/13 (61.5%) group 7/10 (70%) achieved PR. ORR DCR 65.2% 100% respectively. Conclusions: These results indicate that AB011, either chemotherapy, manageable profile encouraging CLDND18.2 PC. Clinical trial information: NCT04400383 .