A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
NCT ID: NCT04275518
Last Updated: 2024-10-15
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
102 participants
INTERVENTIONAL
2020-07-06
2025-12-31
Brief Summary
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APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models.
This is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R/R AML or MDS subjects.
Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).
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Detailed Description
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Stage 2: After stage 1 of APG-115 single agent dose escalation first cycle is completed, stage 2 can be initiated with the combination regimen. This will be a 3+3 dose escalation to determine the MTD/RP2D and DLTs of APG-115 + AZA(arm A)/Cytarabine (arm B)combination.
Stage 3: dose expansion of the combination regimes.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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APG-115/APG-115+Cytarabine in Relapse/Refractory AML
APG-115
APG-115 orally once daily from Days 1 to 7 every 28 days.
Cytarabine
1g/m\^2 IV QD on Days 3-7 (28-day cycle)
APG-115/APG-115+Aza in relapsed/progressed high risk MDS
APG-115
APG-115 orally once daily from Days 1 to 7 every 28 days.
Azacitidine
75 mg/m\^2 SC QD on Days 1- 7 (28-day cycle)
Interventions
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APG-115
APG-115 orally once daily from Days 1 to 7 every 28 days.
Azacitidine
75 mg/m\^2 SC QD on Days 1- 7 (28-day cycle)
Cytarabine
1g/m\^2 IV QD on Days 3-7 (28-day cycle)
Eligibility Criteria
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Inclusion Criteria
2. Age \>/= 18 years.
3. Adequate organ function
4. Subject must have a projected life expectancy of at least 12 weeks.
5. ECOG performance status of 0-1.
6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
7. Subject has a white blood cell count\< 50 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.
Exclusion Criteria
2. Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug, or less than 5 half-lives small molecular targeted drug therapy, or 28 days any anti-cancer therapy (whichever is longer)
3. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
4. Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection.
5. Participants who have received allogeneic HSCT, or autologous HSCT within 12 months.
6. Patients with active, uncontrolled CNS leukemia will not be eligible.
7. Any prior systemic MDM2-p53 inhibitor treatment
8. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
9. Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:
* Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor.
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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Jianxiang Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Blood Diseases Hospital Chinese Academy of Medical Sciences
Locations
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The First Hospital of Peking University
Beijing, Beijing Municipality, China
Guangzhou panyu central hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Henan Provincial Oncology Hospital
Zhengzhou, Henan, China
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affilated Hospital of Ganzhou Medical University
Suzhou, Jiangsu, China
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
Shanghai Jiao Tong University school of medicine Ruijing Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth people's Hospital
Shanghai, Shanghai Municipality, China
Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qian Jiang, Ph.D
Role: primary
Shuqin Cheng, Master
Role: primary
Hui Yang Professor
Role: backup
Yu Zhang, Master
Role: primary
Xudong Wei, M.D.
Role: primary
Qiubo Li, Doctor
Role: primary
Fuling Zhou, M.D.
Role: primary
Jianying Huang Director
Role: backup
Qun He, Master
Role: primary
Qun Qin, M.D.
Role: backup
Liping Liu, Ph.D.
Role: primary
Xiaowen Tang, Doctor
Role: primary
Fei Li, Ph.D.
Role: primary
Sujun Gao, M.D.
Role: primary
Junmin Li Professor
Role: primary
Chunkang Chang Professor
Role: primary
Other Identifiers
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APG115AC101
Identifier Type: -
Identifier Source: org_study_id
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