SHANGHAI, Jan. 28, 2026 /PRNewswire/ — QureBio Ltd., a clinical-stage biotech company focusing on development of bispecific antibodies and other engineered Biopharmaceuticals for the treatment of cancer, inflammation, and other serious disorders, today revealed in 2026 ASCO abstract submission about the Phase Ib/II Clinical Data of its Q-1802 program.
The report（Abstract #537934）is titled “PhaseⅠ/Ⅱ Trial of Anti-CLDN18.2/PD-L1 Recombinant Humanized Bispecific Antibody Q-1802 Plus XELOX in Treatment-Naive CLDN18.2-Positive Advanced GC/GEJ”
The authors, Dr. Gong et al, reported the followings : the study enrolled 62 Eligible pts: CLDN18.2-positive (≥40% tumor cells with 2+/3+ membranous staining), HER2-negative, treatment-naïve, histologically confirmed unresectable locally advanced/metastatic GC/GEJ. Pts received Q-1802 (10 mg/kg or 20 mg/kg Q2W) plus standard XELOX.
In this study, no DLT observed; MTD not reached. Most common Q-1802-related ≥3 Grade TEAE: thrombocytopenia (8.1%), followed by neutropenia (6.5%), anemia, WBC decrease, hypokalemia (4.8% each). Rate of Q-1802 permanent discontinuation due to TEAEs: 6.5%; no treatment-related death.
In all 60 efficacy-evaluable pts, ORR, DCR and mPFS were 70.0% (42/60), 98.3% (59/60), and 11.3 months respectively. In the 10 mg/kg cohort, ORR and mPFS were 73.0% (27/37) and 11.3 months in pts with CLDN18.2 high expression; ORR and mPFS were improved to be 81.8% and 12.2 months when CLDN18.2 high expression accompanied with PD-L1 CPS≥5 (N=11).
The authors, Dr. Gong et al, concluded that Q-1802 plus XELOX has manageable safety and promising antitumor activity as first-line therapy for CLDN18.2-positive/HER2-negative advanced GC/GEJ, supporting a phase III trial with Q-1802 10 mg/kg as recommended dose.
Q-1802 phase III trial has recently been approved by Chinese CDE.
About Q-1802
Q-1802, a humanized Claudin18.2/PD-L1 bispecific antibody, kills tumors by both innate immunity such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP) as well as adaptive immunity involving DC and T cells. It is a powerful agent with good safety profile, offering a novel therapeutic opportunity to patients with Claudin18.2 positive solid tumors. Q-1802 exhibits high affinity and selectivity.
About QureBio Ltd.
QureBio Ltd. is a clinical-stage biotech company focusing on innovative biopharmaceuticals for urgent and unmet clinical needs, such as the treatment of refractory cancers, inflammation and other serious disorders, founded by experienced scientists from the relevant fields, QureBio Ltd. has built up a series of proprietary technologies for engineered bio-macromolecules, including innovative platforms for bi-specific and tri-specific antibodies.
Founded in 2017 with seed capital from Viva Fund, QureBio Ltd. has since received a series of funds from Jundu Investment, Watson Capital, Shenzhen Capital Group, New value Capital, Ningbo Yaluo Venture Capital ,Bocom Industrial Investment (Hangzhou) Equity Investment Partnership, Suzhou Oriza Holdings, Hangzhou CAPITAL GuoShun, Zhuhai Longmen Capital Management, Shanghai Pudong Kechuang Group, Shenzhen Lihe Hongxin Venture, Three Rivers Capital and Efung Capital .
QureBio Ltd. engages in collaboration with partners to develop novel therapeutics for unmet medical needs and has on-going cooperation with a series of industrial partners including Precision Scientific, and Hengrui Pharmaceuticals.
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SOURCE QureBio Ltd.
