Clinical Trial

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Recruiting Phase 2/3
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Summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-17; most recent amendment 2025-11-18.
Status change: Not Yet Recruiting → Recruiting 2024-08-15
Trial Details
NCT Number NCT06378138
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Hematologic Malignancies
Enrollment 226 participants
Start Date 2024-05-15
Primary Completion 2030-11-25 (estimated)
Study Completion 2031-07-25 (estimated)
Updated on ClinicalTrials.gov 2025-11-21