ICP-248
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd., InnoCare Pharma Inc.
Conditions
Acute Myelogenous LeukemiaHematologic MalignanciesHematological MalignanciesMature B-cell MalignanciesMyelodysplastic Syndromes (MDS)Relapsed or Refractory Mantle Cell Lymphoma (MCL)Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Phase 1
The Study of ICP-248 in Patients With Mature B-cell Malignancies
RecruitingNCT05728658
Start: 2023-03-09End: 2026-10-30Target: 191Updated: 2025-09-08
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
RecruitingNCT06351527
Start: 2024-04-23End: 2027-10-25Target: 78Updated: 2025-06-19
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
RecruitingNCT06656494
Start: 2024-12-18End: 2028-01-01Target: 266Updated: 2026-08-18
Phase 2
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
RecruitingNCT06378138
Start: 2024-05-15End: 2031-07-25Target: 226Updated: 2025-11-21
A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
RecruitingNCT07082686
Start: 2025-08-21End: 2028-07-01Target: 75Updated: 2026-07-23
Phase 3
A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).
Not yet recruitingNCT07784101
Start: 2026-10-01End: 2033-12-01Target: 280Updated: 2026-08-25
Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma
Not yet recruitingNCT07896590
Start: 2026-10-01End: 2032-01-01Target: 292Updated: 2026-10-27