Loading
A tight-junction protein normally hidden in the stomach lining that becomes exposed in gastric and pancreatic cancers. This dossier gathers the 16 products (2 approved), 29 trials, 1 pathway and 0 resistance routes in the corpus that involve it, with external identifiers so it can be joined to UniProt, ChEMBL, Open Targets and the rest of biology.
Splice isoform 18.2; expressed in ~30-40% of gastric/GEJ adenocarcinomas and a subset of pancreatic ductal adenocarcinoma.
| Cancer | Prevalence | Measure | Note | Source |
|---|---|---|---|---|
| Pancreatic ductal adenocarcinoma | 20-60% | IHC, any expression | Wide range across series | Wikipedia |
| Gastric & gastro-oesophageal junction cancer | 35-40% | IHC 2+/3+ in >=75% of cells (zolbetuximab definition) | SPOTLIGHT/GLOW screening | Wikipedia |
Approximate, population-level figures; the measure column says what was counted. Ranges show the midpoint as a bar.
| Modality | Approved | Phase 3 | Phase 2 |
|---|---|---|---|
| ADC 6 | - | ||
| Antibody 4 | |||
| Bispecific antibody 3 | - | ||
| Cell therapy 2 | - | ||
| fusion protein 1 | - | - |
| Trial | Setting | Result | Products | ||
|---|---|---|---|---|---|
CLARITY-Gastric 01 NCT06346392 | 3 | Positive | Second- or later-line CLDN18.2-positive advanced gastric/GEJ cancer: sonesitatug vedotin (AZD0901/CMG901) vs investigator's choice | Co-primary endpoints including OS met (July 2026); numbers pending. | |
SPOTLIGHT & GLOW NCT03504397 | 3 | Positive | First-line CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy | SPOTLIGHT OS 18.2 vs 15.5 months; GLOW OS 14.4 vs 12.2 months. | |
| 3 | Recruiting | A Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants With Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received>=2 Prior Lines of Therapy | - | ||
| 3 | Recruiting | A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive | - | ||
| 3 | Recruiting | A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive | - | ||
| 3 | Recruiting | A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | - | ||
| 3 | Recruiting | A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma | - | ||
| 3 | Recruiting | A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02) | - | ||
| 2 | Recruiting | An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer. | - | ||
| 2 | Recruiting | A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC) | - | ||
| 2 | Active | A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive | - | ||
| 2 | Active | A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma | - | ||
| 2 | Recruiting | A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01) | - | ||
| 2 | Planned | An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer | - | ||
| 2 | Planned | A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer | - | ||
| 2 | Recruiting | A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer | - | ||
| 2 | Recruiting | A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of IBI343 in Combination Therapy for Patients With Advanced Malignant Solid Tumors. | - | ||
CT041-ST-01 NCT04581473 | 1/2 | Positive | CLDN18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines, China: satricabtagene autoleucel versus treatment of physician's choice | Median progression-free survival 3.25 vs 1.77 months (hazard ratio 0.37) in 156 randomised patients. | |
| 1/2 | Recruiting | A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer | - | ||
| 1/2 | Recruiting | An Open, Multi-center Phase I/IIa Clinical Study of RC118 for Injection in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors with Positive Expression of Claudin 18.2 | - | ||
| 1/2 | Recruiting | A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab / RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors | - | ||
| 1/2 | Recruiting | A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors | - | ||
| 1/2 | Recruiting | A Phase Ib/II, Open, Dose-escalation and Expansion Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors | - | ||
| 1/2 | Recruiting | A Phase Ib/II Study to Evaluate the Safety, Tolerability and Efficacy of IBI343 in Combination With Chemotherapy in Subjects With Advanced Pancreatic Cancer | - | ||
| 1/2 | Recruiting | A Phase 1/2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and/or an Immune ChecKpoint Inhibitor. The TWINPEAK Study | - | ||
| 1/2 | Active | A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours | - | ||
| 1/2 | Recruiting | A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors | - | ||
| 1/2 | Active | A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects With Unresectable, Locally Advanced or Metastatic Claudin 18.2+ Solid Tumors | - | ||
| 1/2 | Active | A Phase I/Ⅱ, First-in-Human Study of XNW27011 in Patients With Locally Advanced and/or Metastatic Solid Tumors | - |
No recorded escape route names this target.
This KEGG map splits stomach cancer into two routes: the intestinal type that accumulates TP53, APC and HER2 changes step by step, and the diffuse type driven by loss of the cell glue E-cadherin plus MET or FGFR2 amplification. It matters because HER2, FGFR2, claudin 18.2 and PD-1 status now decide first-line treatment.
Which nodes have drugs →| Assay | Platform | Cut-off | Gates |
|---|---|---|---|
| VENTANA CLDN18 (43-14A) RxDx Assay Roche Diagnostics · FDA CDx 2024 | IHC | At least 75% of tumour cells with moderate-to-strong membranous staining (zolbetuximab, gastric and gastro-oesophageal junction adenocarcinoma) |
No model entry for this target yet; check the cancer entries on the models page.
Why unresolved. Zolbetuximab needs at least 75% moderate-to-strong staining; ADCs such as CMG901 and the Chinese-approved satri-cel appear active at lower expression, but no trial compares modalities or thresholds.
What would answer it. Randomised trials in CLDN18.2-positive gastric cancer with stratification by expression level, and a harmonised IHC assay across modalities.
Query for this target: (TITLE:"Claudin 18.2" OR ABSTRACT:"Claudin 18.2" OR TITLE:"CLDN18" OR ABSTRACT:"CLDN18") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Claudin 18.2, not a curated reading list.
The dossier as machine-readable JSON, at /api/v1/dossiers/cldn18-2.json: identifiers from HGNC, Ensembl, UniProt and ChEMBL, products with status, trials, pathways, hotspots, open questions and assays. The full entity record is in the open API at /api/v1/entities/cldn18-2.json. Licence CC BY-NC 4.0.