{"entity":{"id":"clarity-gastric01","kind":"trial","name":"CLARITY-Gastric 01","aka":[],"tldr":"The first ADC against Claudin 18.2 to prove it extends life, announced July 2026, giving stomach cancer its first ADC beyond HER2.","summary":"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.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06346392","url":"https://clinicaltrials.gov/study/NCT06346392"},{"label":"ASCO GI 2025 trial-in-progress","url":"https://ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS507"}],"tags":[],"related":[],"cancers":["gastric"],"sections":[],"technologies":["adc"],"targets":["cldn18-2"],"drugs":["cmg901","ramucirumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06346392","phase":"3","setting":"Second- or later-line CLDN18.2-positive advanced gastric/GEJ cancer: sonesitatug vedotin (AZD0901/CMG901) vs investigator's choice","sponsor":"AstraZeneca","result":"Co-primary endpoints including OS met (July 2026); numbers pending.","started":"2024-03-04","startedType":"actual","yearReported":2026,"enrolled":594,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, third-line or later (dual primary)","primary":true,"unit":"months","arms":[{"name":"Sonesitatug vedotin 2.2 mg/kg","note":"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."},{"name":"Investigator's choice chemotherapy"}],"source":"https://www.cancernetwork.com/view/sonesitatug-vedotin-improves-overall-survival-in-cldn18-2-gastric-cancer"},{"endpoint":"Progression-free survival (BICR), second-line or later (dual primary)","primary":true,"unit":"months","arms":[{"name":"Sonesitatug vedotin 2.2 mg/kg","note":"Trend favouring sonesitatug vedotin; did not reach statistical significance"},{"name":"Investigator's choice chemotherapy"}],"source":"https://www.cancernetwork.com/view/sonesitatug-vedotin-improves-overall-survival-in-cldn18-2-gastric-cancer"}],"replication":"First phase 3 OS win for a CLDN18.2 ADC; builds on the phase 1 KYM901 signal and on zolbetuximab (SPOTLIGHT/GLOW) validating the target in first line. Numbers awaited."},"route":"/trials/clarity-gastric01/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cldn18-2","kind":"target","name":"Claudin 18.2","route":"/targets/cldn18-2/"}],"drug":[{"id":"ramucirumab","kind":"drug","name":"Ramucirumab","route":"/drugs/ramucirumab/"},{"id":"cmg901","kind":"drug","name":"Sonesitatug vedotin","route":"/drugs/cmg901/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"pairing":[{"id":"cldn18-antibody-then-adc","kind":"pairing","name":"CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression","route":"/pairings/cldn18-antibody-then-adc/"}]}}