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The first ADC against Claudin 18.2 to prove it extends life, announced July 2026, giving stomach cancer its first ADC beyond HER2.
CLARITY-Gastric 01, trial NCT06346392 sponsored by AstraZeneca and announced in July 2026, is the first phase 3 to prove that an antibody-drug conjugate against Claudin 18.2 extends life, giving stomach cancer its first ADC beyond HER2. It randomised 594 patients with second- or later-line CLDN18.2-positive advanced gastric or gastro-oesophageal junction cancer to sonesitatug vedotin, also known as AZD0901 or CMG901, or investigator's choice chemotherapy, and met its co-primary overall survival endpoint in third-line or later disease, with survival in the whole population also significant and progression-free survival trending favourably; full data await presentation. OnCo links it to gastric and oesophageal cancer, Claudin 18.2 as a target, sonesitatug vedotin and ramucirumab. Whether the drug works after zolbetuximab is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
594 enrolled.
Met with a statistically significant, clinically meaningful improvement per the sponsor (27 July 2026); OS in the whole second-line-or-later population (key secondary) also significant. Medians and hazard ratios pending presentation.
SourceTrend favouring sonesitatug vedotin; did not reach statistical significance
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, third-line or later (dual primary)primary | Sonesitatug vedotin 2.2 mg/kg | - | Met with a statistically significant, clinically meaningful improvement per the sponsor (27 July 2026); OS in the whole second-line-or-later population (key secondary) also significant. Medians and hazard ratios pending presentation. | - | - | link |
| Investigator's choice chemotherapy | - | - | ||||
| Progression-free survival (BICR), second-line or later (dual primary)primary | Sonesitatug vedotin 2.2 mg/kg | - | Trend favouring sonesitatug vedotin; did not reach statistical significance | - | - | link |
| Investigator's choice chemotherapy | - | - |
Shares Sonesitatug vedotin, Oesophageal cancer, AstraZeneca, Gastric & gastro-oesophageal junction cancer.
Shares Claudin 18.2, Oesophageal cancer, AstraZeneca, Gastric & gastro-oesophageal junction cancer.
Shares Sonesitatug vedotin, Claudin 18.2, Gastric & gastro-oesophageal junction cancer, Antibody-drug conjugate (ADC).
Shares Ramucirumab, Oesophageal cancer, AstraZeneca, Gastric & gastro-oesophageal junction cancer.
Shares Ramucirumab, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
Shares Claudin 18.2, AstraZeneca, Gastric & gastro-oesophageal junction cancer.
Shares Ramucirumab, Gastric & gastro-oesophageal junction cancer, Antibody-drug conjugate (ADC).
Shares Claudin 18.2, Ramucirumab, Gastric & gastro-oesophageal junction cancer.