On January 28, 2026 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, reported in 2026 ASCO (Free ASCO Whitepaper) abstract submission about the Phase Ib/II Clinical Data of its Q-1802 program.
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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.
(Press release, QureBio, JAN 28, 2026, View Source [SID1234662336])