Zolbetuximab-clzb is marketed as Vyloy, a CLDN18.2-targeted monoclonal antibody for first-line treatment of advanced HER2-negative CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma with fluoropyrimidine- and platinum-based chemotherapy. It is FDA approved.
VYLOY (zolbetuximab-clzb) remains the only approved CLDN18.2-targeted therapy for first-line HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. The pipeline is focused on next-generation antibodies, ADCs, CAR-T, NK-cell and bispecific approaches aiming to build on zolbetuximab benchmark data.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
New ASCO guideline emphasizes biomarker-driven treatment for advanced gastroesophageal cancer, recommending upfront testing for HER2, PD-L1, MSI/MMR, and CLDN18.2 to guide immunotherapy and targeted therapy selection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07431281 |
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 |
RECRUITING | PHASE3 |
| NCT06962137 |
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer |
RECRUITING | PHASE2 |
| NCT06902545 |
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer. |
RECRUITING | |
| NCT06901531 |
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer |
RECRUITING | PHASE3 |
| NCT06881017 |
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping |
NOT_YET_RECRUITING | PHASE2 |
| NCT06732856 |
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT06468280 |
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer |
RECRUITING | PHASE2 |
| NCT06396091 |
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06048081 |
Early Access Program for Zolbetuximab |
AVAILABLE | |
| NCT04086758 |
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma |
COMPLETED | PHASE1 |
