{"entity":{"id":"apex-03","kind":"trial","name":"ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)","aka":["APEX-03"],"tldr":"A phase 2/3 trial testing ICP-248 in chronic lymphocytic leukaemia, now recruiting.","summary":"ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (APEX-03) is a phase 2/3 interventional study registered as NCT06378138, led by Beijing InnoCare Pharma Tech, and recruiting on the registry. Official title: A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma. Planned enrolment is 226 participants (estimated). The study started in 2024-05-15 and primary completion is expected in 2030-11-25. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06378138","url":"https://clinicaltrials.gov/study/NCT06378138"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cll","cll-treatment-naive"],"sections":[],"technologies":[],"targets":[],"drugs":["icp-248"],"companies":["innocare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06378138","phase":"2/3","setting":"A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","sponsor":"Beijing InnoCare Pharma Tech","started":"2024-05-15","startedType":"actual","enrolled":226,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/apex-03/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first treatment","route":"/cancers/cll-treatment-naive/"}],"drug":[{"id":"icp-248","kind":"drug","name":"ICP-248","route":"/drugs/icp-248/"}],"company":[{"id":"innocare","kind":"company","name":"InnoCare Pharma","route":"/companies/innocare/"}]}}