{"entity":{"id":"hlx22","kind":"drug","name":"HLX22","aka":[],"tldr":"HLX22 is an experimental monoclonal antibody from Shanghai Henlius Biotech in phase 3 trials for gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer, aimed at HER2.","summary":"HLX22 is a monoclonal antibody developed by Shanghai Henlius Biotech. Its target is HER2 (the sponsor names HER2). The sponsor states: HLX22 is a recombinant humanised anti-HER2 monoclonal antibody injection, given at 15 mg/kg every three weeks in combination with trastuzumab and chemotherapy (XELOX) in HER2-positive gastric or gastroesophageal junction adenocarcinoma. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT06532006 (A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer), in gastric & gastro-oesophageal junction cancer and HR-positive / HER2-negative breast cancer. The largest, NCT06532006, plans to enrol 550 participants with primary completion expected 2027-06-01. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of HLX22","url":"https://clinicaltrials.gov/search?intr=HLX22"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["gastric","breast-hr-positive"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06532006","nct06832202"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"monoclonal antibody","mechanism":"HLX22 is a recombinant humanised anti-HER2 monoclonal antibody injection, given at 15 mg/kg every three weeks in combination with trastuzumab and chemotherapy (XELOX) in HER2-positive gastric or gastroesophageal junction adenocarcinoma.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/hlx22/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}],"trial":[{"id":"nct06832202","kind":"trial","name":"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients","route":"/trials/nct06832202/"},{"id":"nct06532006","kind":"trial","name":"A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","route":"/trials/nct06532006/"}]}}