{"entity":{"id":"cmg901","kind":"drug","name":"Sonesitatug vedotin","aka":[],"tldr":"Sonesitatug vedotin is a Claudin 18.2 ADC in phase 3 for gastric cancer, licensed by AstraZeneca from KYM Biosciences.","summary":"Sonesitatug vedotin (CMG901) is an anti-Claudin 18.2 antibody carrying the microtubule inhibitor MMAE through a cleavable linker; Claudin 18.2 is a tight-junction protein normally buried in gastric mucosa but exposed on gastric and some pancreatic cancer cells, giving the ADC a tumour-selective address. AstraZeneca licensed global rights from KYM Biosciences in 2023. Phase 1 produced an objective response rate around 33 percent in CLDN18.2-positive gastric cancer, and the CLARITY-Gastric01 phase 3 trial is testing it at 2.2 mg/kg every 3 weeks in second-line gastric cancer. Nausea, vomiting, neutropenia and decreased appetite are the main toxicities, the gut effects reflecting on-target binding to normal stomach lining. It competes with XNW27011 and other CLDN18.2 ADCs, so randomised data will decide the field. It delivers a cell poison to a protein hidden in healthy tissue.","status":"phase-3","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov: trials of Sonesitatug vedotin","url":"https://clinicaltrials.gov/search?intr=CMG901"}],"tags":[],"related":[],"cancers":["gastric","pancreatic"],"sections":[],"technologies":["adc"],"targets":["cldn18-2"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06219941","nct07431281","nct07069712"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"CMG901, AZD0901","modality":"ADC","payload":"MMAE","linker":"Cleavable","mechanism":"Anti-CLDN18.2 with MMAE.","approvals":[],"mechanismSteps":["Antibody binds Claudin 18.2 on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","MMAE is released inside the cell","Microtubule assembly is blocked; mitosis arrests","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"2.2 mg/kg every 3 weeks (phase 3 dose)","source":"https://clinicaltrials.gov/study/NCT06346392"},"toxicity":[{"event":"Nausea"},{"event":"Vomiting"},{"event":"Neutropenia"},{"event":"Decreased appetite"}],"access":[{"country":"US","reimbursement":"Investigational (CLARITY-Gastric01)","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-02","type":"filing","region":"US","note":"AstraZeneca licenses global rights from KYM Biosciences","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/cmg901/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"gastric-cldn18-2-positive","kind":"cancer","name":"Claudin 18.2-positive gastric cancer","route":"/cancers/gastric-cldn18-2-positive/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"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/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"keymed","kind":"company","name":"Keymed Biosciences (KYM Biosciences)","route":"/companies/keymed/"}],"trial":[{"id":"nct07069712","kind":"trial","name":"A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma","route":"/trials/nct07069712/"},{"id":"nct06219941","kind":"trial","name":"AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","route":"/trials/nct06219941/"},{"id":"clarity-gastric01","kind":"trial","name":"CLARITY-Gastric 01","route":"/trials/clarity-gastric01/"},{"id":"nct07431281","kind":"trial","name":"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","route":"/trials/nct07431281/"}],"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/"}],"term":[{"id":"mmae","kind":"term","name":"MMAE","route":"/terms/mmae/"},{"id":"tubulin-inhibitor-payloads","kind":"term","name":"Tubulin inhibitor payloads","route":"/terms/tubulin-inhibitor-payloads/"}]}}