CLDN1 positive

This review explores recent research progress in immunotherapy for gastric cancer with specific molecular subtypes, including HER2-positive, Claudin18.2-positive, dMMR/MSI-H, Epstein-Barr virus (EBV)-positive, and alpha-fetoprotein (AFP)-positive subtypes. The aim is to provide insights for developing personalized and precise treatment strategies for gastric cancer patients with different molecular subtypes and clinical stages.

P3, N=752, Not yet recruiting, Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Although non-Asian patients also demonstrated a trend toward improved survival, the difference was not statistically significant. Further studies are needed to explore the therapeutic and clinical implications of CLDN18.2 expression in diverse populations worldwide.

P1/2, N=280, Recruiting, AstraZeneca | Trial completion date: Dec 2026 --> Jun 2027 | Trial primary completion date: Dec 2026 --> Jun 2027

Combined CLDN18.2/CD8+ TILs stratification enhances prognostic precision and suggests synergistic potential for CLDN18.2 targeted therapies with immunomodulation. These findings warrant clinical validation to guide personalized treatment strategies.

The correlations between the expression of CLDN18.2 and clinicopathological characteristics and prognosis suggest that early-stage patients could benefit more from future anti-CLDN18.2 treatment and that CLDN18.2 may function as a pivotal regulatory molecule in patients with GBC. The underlying mechanism may be related to immune activation caused by high CLDN18.2 expression.

Characterizing unresectable, metastatic, or recurrent GC with positive CLDN18.2 expression and evaluating intratumoral heterogeneity and prognostic implications of various therapeutics help advance treatment strategies and develop new therapies for patients with GC.

Question The study resolves the clinical issue of determining the correlation between [18F]FDG PET/CT imaging and claudin 18.2 expression in metastatic gastric cancer. Findings Claudin 18.2-positive metastatic gastric cancers exhibit relatively lower [18F]FDG uptake than negative ones. The SUVmax of 10.9 moderately predicts claudin 18.2 expression. Clinical relevance [18F]FDG PET/CT imaging could be a noninvasive way to predict claudin 18.2 status in metastatic gastric cancer, helping to improve personalized treatment plans.

CK7 + tumors showed intriguingly common (31.6%) BRAF V600E mutations corelating with poor prognosis, compared to the frequency described in the literature and databases. Further research on larger cohorts with a non-colorectal immunophenotype and high MUC4 expression is needed.

CLDN18.2-positive GC is associated with poor prognosis and worse immunotherapeutic outcomes. The combination of anti-CLDN18.2 therapy, anti-PD-L1/PD-1 therapy, and chemotherapy for GC requires further investigation.

Data suggested CLDN18.2 expression levels were independent of PD-L1 status, and support the use of Transcenta 14G11 antibody for CLDN18.2 detection regardless of sample collection methods, location, and patient demographics. An anti-CLDN18.2 companion diagnostic device based on 14G11 is being developed (CLDN18.2 IHC 14G11 pharmDx, Agilent Technologies, Inc.).

P1/2, N=135, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Sep 2025