Alrizomadlin

Generic Name: Alrizomadlin

Drug Type: Small Molecule

Chemical Formula: C_₃₄H_₃₈Cl_₂FN_₃O_₄

CAS Number: 1818393-16-6

Unique Ingredient Identifier: 15QAU0SI9J

Background: Alrizomadlin is a novel MDM2 inhibitor that blocks the interaction of MDM2 and p53. It is being investigated in cancers.

Clinical Trials

Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST

Phase 1

Not yet recruiting

Conditions: Malignant Peripheral Nerve Sheath Tumor (MPNST)
Neurofibromatosis 1 (NF1)
Atypical Neurofibroma

Interventions: Drug: APG-115
Drug: Selumetinib

First Posted Date: 2024-12-16

Last Posted Date: 2024-12-16

Lead Sponsor: AeRang Kim

Target Recruit Count: 45

Registration Number: NCT06735820

Locations: 🇺🇸
Children's National Hospital, Washington, District of Columbia, United States

Alrizomadlin (APG-115) in Subjects With BAP1 Cancer Syndrome and Early-Stage Mesothelioma

Phase 2

Not yet recruiting

Conditions: Mesothelioma
Malignant Mesothelioma (MM)
Early-stage Mesothelioma
Subclinical Mesothelioma
BRCA1-Associated Protein-1 (BAP1) Mutations
Early-stage BAP1-associated Malignancies

Interventions: Drug: alrizomadlin

First Posted Date: 2024-10-23

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT06654050

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors

Phase 1

Recruiting

Conditions: Neuroblastoma
Solid Tumor

Interventions: Drug: APG-115
Drug: APG-2575

First Posted Date: 2023-01-27

Last Posted Date: 2025-02-25

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 100

Registration Number: NCT05701306

Locations: 🇨🇳
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
🇨🇳
Tongji Hospital, Huazhong University of Science and Technology (HUST), Wuhan, Hubei, China

APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Liposarcoma
Advanced Solid Tumor

Interventions: Drug: APG-115
Drug: Toripalimab

First Posted Date: 2021-03-05

Last Posted Date: 2025-02-26

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 95

Registration Number: NCT04785196

Locations: 🇨🇳
Cancer Hospital of The University of Chinese Academy of Sciences, Hangzhou, Zhejiang, China
🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
🇨🇳
Shanghai East Hospital (East Hospital affiliated to Tongji University), Shanghai, China

A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

Phase 2

Recruiting

Conditions: Non-Hodgkins Lymphoma
T-Prolymphocytic Leukemia

Interventions: Drug: APG-115
Drug: APG-2575

First Posted Date: 2020-08-03

Last Posted Date: 2024-08-19

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 78

Registration Number: NCT04496349

Locations: 🇺🇸
Ohio State University, Columbus, Ohio, United States
🇺🇸
MD Anderson, Houston, Texas, United States
🇺🇸
City of Hope, Duarte, California, United States

A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS

Phase 1

Recruiting

Conditions: AML
CMML
Myelodysplastic Syndromes
MDS
Chronic Myelomonocytic Leukemia
High-risk Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Drug: APG-115
Drug: 5-azacitidine

First Posted Date: 2020-04-24

Last Posted Date: 2024-02-01

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 69

Registration Number: NCT04358393

Locations: 🇺🇸
Texas Oncology - Tyler, Tyler, Texas, United States
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
Rocky Mountain Cancer Centers, Denver, Colorado, United States

and more 5 locations

A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)
Myelodysplastic Syndromes (MDS)

Interventions: Drug: APG-115
Drug: Cytarabine
Drug: Azacitidine

First Posted Date: 2020-02-19

Last Posted Date: 2024-10-11

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 102

Registration Number: NCT04275518

Locations: 🇨🇳
Xiangya Hospital Central South University, Changsha, Hunan, China
🇨🇳
The First Affilated Hospital of Ganzhou Medical University, Suzhou, Jiangsu, China
🇨🇳
Guangzhou panyu central hospital, Guangzhou, Guangdong, China

and more 11 locations

APG-115 in Salivary Gland Cancer Trial

Phase 1

Active, not recruiting

Conditions: Malignant Salivary Gland Cancer
Salivary Gland Cancer

Interventions: Drug: APG-115
Drug: Carboplatin

First Posted Date: 2018-12-20

Last Posted Date: 2025-01-14

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 41

Registration Number: NCT03781986

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

APG-115 in Patients With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Patients With Advanced Solid Tumor or Lymphoma

Interventions: Drug: APG-115

First Posted Date: 2016-10-18

Last Posted Date: 2022-07-12

Lead Sponsor: Ascentage Pharma Group Inc.

Target Recruit Count: 50

Registration Number: NCT02935907

Locations: 🇺🇸
The START Center for Cancer Care, San Antonio, Texas, United States
🇺🇸
START Midwest, Grand Rapids, Michigan, United States

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