Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
NCT ID: NCT04501120
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
458 participants
INTERVENTIONAL
2020-09-28
2029-09-30
Brief Summary
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Detailed Description
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This study consists of three stages: The first stage is the Lisaftoclax (APG-2575) single agent dose-escalation study. The second stage is the Lisaftoclax (APG-2575) combined with HHT/AZA dose-escalation study. The third stage is the MTD/RP2D expansion cohort study of the combination regimen.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lisaftoclax (APG-2575) single agent
Lisaftoclax (APG-2575) orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg, to determine the MTD/RP2D.
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Lisaftoclax (APG-2575)+reduced-dose HHT
Lisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with reduced-dose HHT in R/R AML, MPAL, BPDCN, CMML.
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Reduced-dose HHT
1mg IV QD on Days 1-14 (28-day cycle).
Lisaftoclax (APG-2575)+ standard-dose HHT
Lisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with standard-dose HHT in R/R AML, MPAL, BPDCN, CMML.
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
standard-dose HHT
2mg/m\^2 IV QD on Days 1-7 (28-day cycle).
Lisaftoclax (APG-2575)+ AZA
Lisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in R/R AML, MPAL, BPDCN, CMML.
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)+ AZA(HR-MDS.)
Lisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in HR-MDS.
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.
Lisaftoclax (APG-2575)+ AZA(Naïve AML.)
Lisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in treatment naïve AML.
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)+AZA+Olverembatinib
Lisaftoclax (APG-2575) combines with AZA and Olverembatinib in R/R AML.
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.
olverembatinib
orally, with meals, QOD, every 28 days as a cycle.
Lisaftoclax (APG-2575)+HHT+Olverembatinib
Lisaftoclax (APG-2575) combines with HHT and Olverembatinib in R/R AML.
standard-dose HHT
2mg/m\^2 IV QD on Days 1-7 (28-day cycle).
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.
olverembatinib
orally, with meals, QOD, every 28 days as a cycle.
Interventions
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Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Reduced-dose HHT
1mg IV QD on Days 1-14 (28-day cycle).
standard-dose HHT
2mg/m\^2 IV QD on Days 1-7 (28-day cycle).
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.
olverembatinib
orally, with meals, QOD, every 28 days as a cycle.
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants \>= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy).
3. Subjects can accept oral administration of Lisaftoclax (APG-2575).
4. Life expectancy ≥ 3 months.
5. Adequate renal and liver function.
6. Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.
7. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
8. Willingness and ability to comply with study procedures and follow-up examination.
Exclusion Criteria
2. The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).
3. Known leukemia infiltration of the central nervous system.
4. Symptomatic active fungal, bacterial and/or viral infections.
5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months.
6. Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment.
7. Within 7 days before the first dose of study drug, received a strong and/or moderate CYP3A inducer and/or Inhibitor.
8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575).
9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Suzhou Yasheng Pharmaceutical Co., Ltd.
INDUSTRY
Ascentage Pharma Group Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yifan Zhai, M.D., Ph.D.
Role: STUDY_DIRECTOR
Suzhou Yasheng Pharmaceutical Co., Ltd.
Jie Jin, M.D.
Role: PRINCIPAL_INVESTIGATOR
the First Affiliated Hospital, College of Medicine
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Henan Tumor Hospital
Zhengzhou, Henan, China
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Hunan university
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Shanghai The Sixth People' s Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Qiang Jiang, Professor
Role: primary
Yi Gong, M.D.
Role: primary
Yang Liang, Professor
Role: primary
Jianyu Wong, M.D.
Role: primary
Xudong Wei, Professor
Role: primary
Qiubo Li, Professor
Role: primary
Fuling Zhou, Professor
Role: primary
Jianying Zhou, Professor
Role: backup
Yajing Xu, Master
Role: primary
Qun He, Master
Role: backup
Suning Chen, M.D.
Role: primary
Chunkang Chang, Professor
Role: primary
Other Identifiers
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APG2575AC101
Identifier Type: -
Identifier Source: org_study_id
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