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ICP-248

DRUG6 trials

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)

Phase 1

The Study of ICP-248 in Patients With Mature B-cell Malignancies
RecruitingNCT05728658
Beijing InnoCare Pharma Tech Co., Ltd.Hematological Malignancies
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
InnoCare Pharma Inc.Mature B-cell Malignancies
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
Beijing InnoCare Pharma Tech Co., Ltd.Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS)
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
Beijing InnoCare Pharma Tech Co., Ltd.Hematologic Malignancies
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
Beijing InnoCare Pharma Tech Co., Ltd.Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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
Beijing InnoCare Pharma Tech Co., Ltd.Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Start: 2026-10-01End: 2033-12-01Target: 280Updated: 2026-08-25

Related Papers

Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies.
Journal of Clinical Oncology2026-05-27
Efficacy and safety of mesutoclax (ICP-248) in combination with orelabrutinib in patients with B-cell malignancies: A pooled analysis.
Journal of Clinical Oncology2026-05-27
Efficacy and tolerability of mesutoclax monotherapy in Relapsed/Refractory Mantle Cell Lymphoma patients: High remission rates even in prior BTKi-refractory patients
Blood2025-11-03
Safety, tolerability and efficacy of mesutoclax to treat patients with myeloid malignancies
Blood2025-11-03
Mesutoclax (ICP-248) monotherapy or combined with orelabrutinib demonstrates encouraging activity and safety in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
Blood2025-11-03
Preliminary safety and efficacy data of ICP-248, a novel BCL2 inhibitor, in patients with relapsed or refractory B-cell malignancies.
Journal of Clinical Oncology2025-05-281 citations
Preliminary Safety, Pharmacological and Efficacy Data from Patients with Relapsed or Refractory B-Cell Malignancies Treated with the ICP-248, a Next Generation BCL2 Inhibitor
Blood2023-11-02