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APG-115

DRUG8 trials

Sponsors

Ascentage Pharma Group Inc., University of Michigan Rogel Cancer Center, AeRang Kim

Conditions

AMLAcute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Advanced Solid TumorAtypical NeurofibromaCMMLChronic Myelomonocytic LeukemiaHigh-risk Myelodysplastic Syndrome

Phase 1

APG-115 in Patients With Advanced Solid Tumors or Lymphomas
CompletedNCT02935907
Ascentage Pharma Group Inc.Patients With Advanced Solid Tumor or Lymphoma
Start: 2016-10-31End: 2019-06-28Updated: 2022-07-12
APG-115 in Salivary Gland Cancer Trial
Active, not recruitingNCT03781986
University of Michigan Rogel Cancer CenterMalignant Salivary Gland Cancer, Salivary Gland Cancer
Start: 2019-10-28End: 2027-01-01Updated: 2026-03-03
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
RecruitingNCT04275518
Ascentage Pharma Group Inc.Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
Start: 2020-07-06End: 2025-12-31Target: 102Updated: 2024-10-15
A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
RecruitingNCT04358393
Ascentage Pharma Group Inc.Acute Myeloid Leukemia, AML, Chronic Myelomonocytic Leukemia +4
Start: 2020-12-04End: 2025-12-30Target: 69Updated: 2024-02-01
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
RecruitingNCT04785196
Ascentage Pharma Group Inc.Advanced Solid Tumor, Liposarcoma
Start: 2021-05-26End: 2027-01-31Target: 95Updated: 2025-02-26
APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors
RecruitingNCT05701306
Ascentage Pharma Group Inc.Neuroblastoma, Solid Tumor
Start: 2023-02-28End: 2027-12-31Target: 100Updated: 2025-02-25
Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST
Not yet recruitingNCT06735820
AeRang KimAtypical Neurofibroma, Malignant Peripheral Nerve Sheath Tumor (MPNST), Neurofibromatosis 1 (NF1)
Start: 2025-10-01End: 2028-10-01Target: 45Updated: 2025-07-03

Phase 2

A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL
RecruitingNCT04496349
Ascentage Pharma Group Inc.Non-Hodgkins Lymphoma, T-Prolymphocytic Leukemia
Start: 2021-07-12End: 2027-05-31Target: 78Updated: 2025-11-04

Related Papers

MDM2 Inhibition with Alrizomadlin (APG-115) in TP53 wild-type salivary gland cancers: a phase I clinical trial
Nature Communications2026-03-19
A phase 2 study of novel MDM2 inhibitor alrizomadlin (APG-115) with or without toripalimab in patients (pts) with advanced adenoid cystic carcinoma (ACC) or other solid tumors.
Journal of Clinical Oncology2025-05-281 citations
Alrizomadlin (APG-115) Alone or Combined with Azacitidine (AZA) in Patients (pts) with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Relapsed or Progressive Higher-Risk Myelodysplastic Syndrome (HR-MDS): Phase 1b Trial Results
Blood2023-11-022 citations
Trial in Progress: Phase 1b/2 Study of Alrizomadlin (APG-115), Alone or Combined with 5-Azacitidine (AZA), in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), or Myelodysplastic Syndrome (MDS)
Blood2022-11-153 citations
450 Trial in progress: A phase 1b study of alrizomadlin, alone or plus 5-azacitidine or cytarabine, in pts with relapsed/refractory acute myeloid leukemia and relapsed higher-risk myelodysplastic syndrome
Regular and Young Investigator Award Abstracts2021-11-011 citations
445 Trial in progress: A phase 1b/2 study of alrizomadlin (APG-115), alone or combined with 5-azacitidine, in patients with relapsed/refractory acute myeloid leukemia (R/R AML)
Regular and Young Investigator Award Abstracts2021-11-01
Hijacking the Pathway: Perspectives in the Treatment of Mature T-cell Leukemias
HemaSphere2021-06-015 citations
Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma.
Journal of Clinical Oncology2021-05-202 citations
A phase I study of a novel MDM2 antagonist APG-115 in patients with advanced solid tumors.
Journal of Clinical Oncology2019-05-2026 citations
A phase Ib/II study of APG-115 in combination with pembrolizumab in patients with unresectable or metastatic melanomas or advanced solid tumors
Annals of Oncology2019-02-0114 citations