CLDN18.2 positive

P=N/A, N=50, Not yet recruiting, Beijing GoBroad Hospital

The approved antibody zolbetuximab requires higher expression levels (≥75% of tumor cells with 2-3+ membranous staining), yet broader thresholds are increasingly explored...Broadening the threshold for positivity identified nearly three-quarters of patients as CLDN18.2 positive, underscoring the impact of selection cut points on trial eligibility. These findings highlight the potential to expand patient access to CLDN18.2-targeted therapies using lower thresholds.

In the remaining HER2 cohort, CLDN18.2-positive patients had shorter PFS (3.2 versus 8.0 months, HR 3.40, 95% CI 1.38-8.40, P = 0.008) and OS (7.1 versus 12.9 months, HR 2.44, 95% CI 1.04-5.74, P = 0.041). CLDN18.2 positivity may attenuate the efficacy of T-DXd in HER2-positive mGC/GEJC, supporting the rationale for dual blockade of CLDN18.2 and HER2.

P3, N=572, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P1, N=13, Terminated, Zhejiang Doer Biologics Co., Ltd. | N=94 --> 13 | Trial completion date: Jun 2025 --> Mar 2026 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Dec 2025; This trial was terminated voluntarily by the Sponsor for reasons related to its corporate strategic development, with no safety concerns or efficacy signals related to the investigational product identified.

In this study, we demonstrated that IBI389 effectively redirects T cells to CLDN18.2-expressing tumors, suppresses tumor growth, and synergizes with PD-1 blockade and has a favorable safety profile. By virtue of its ability to enhance immune infiltration, remodel cytokine responses, and reduce tumor-immune spatial separation, IBI389 may have considerable potential as a novel therapeutic strategy for CLDN18.2-positive gastric cancer and related malignancies.

The developed 1⁸F-FDG PET/CT-based multimodal radiomics model serves as an effective, non-invasive tool for predicting CLDN18.2 expression in GAC. The study validates the hypometabolic nature of CLDN18.2-positive tumors, suggesting this radiomics approach can effectively complement traditional biopsy methods for patient stratification.

A mean of 3.4 outpatient visits per patient per month was reported (mean follow-up, 6.5 months), 21.0% of patients had an inpatient admission, and 35.5% had an emergency department visit. This study demonstrates substantial disease-related symptom burden and high HRU for patients with CLDN18.2+, HER2-, LA unresectable or mG/GEJ adenocarcinoma.

P2, N=151, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=389, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.