A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
NCT ID: NCT04358393
Last Updated: 2024-02-01
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
69 participants
INTERVENTIONAL
2020-12-04
2025-12-30
Brief Summary
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Detailed Description
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Part 2: Dose escalation of APG-115 in combination with 5-AZA will use standard 3+3 design. 5-AZA is administered at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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APG-115 monotherapy
Monotherapy given in part 1
APG-115
APG-115 given once daily on day 1-5 of every 28 day cycle
APG-115 + 5-azacitidine combination
Combination therapy given in part 2
APG-115
APG-115 given once daily on day 1-5 of every 28 day cycle
5-azacitidine
5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days
Interventions
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APG-115
APG-115 given once daily on day 1-5 of every 28 day cycle
5-azacitidine
5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adequate organ function as defined below:
1. Liver function (total bilirubin \< or = 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<3 x ULN
2. Kidney function (defined as a calculated creatinine clearance ≥ 60 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula)
3. Known cardiac ejection fraction of \> or = 45% within the past 3 months
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
4. A negative serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
5. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or legally authorized representative is required prior to their enrollment on the protocol.
6. Subject must have a projected life expectancy of at least 12 weeks.
7. Subject has a white blood cell count \< 25 × 10˄9/L. Note: Hydroxyurea is permitted to meet this criteria.
Exclusion:
1. Pregnant women are excluded.
2. 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.
3. Have had leukemia therapy for 14 days prior to starting investigational drug. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study.
4. Have acute promyelocytic leukemia.
5. Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection.
6. Have received allogeneic hematopoietic stem cell transplant (HSCT) within 12 months prior to the first dose, or who have active/ongoing graft-versus host disease (GVHD), or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose), or received autologous hematopoietic stem cell transplantation within 6 months prior to the first dose.
7. Documented hypersensitivity to any of the components of the therapy program
8. Active, uncontrolled central nervous system (CNS) leukemia will not be eligible.
9. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation.
10. Any prior systemic MDM2-p53 inhibitor treatment
11. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
12. History of other malignancies within 2 years prior to study entry, with the exception of:
1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast
2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
3. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor
13. Failure to have recovered (Grade \> 1) from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery)
14. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, or corrected QT interval (QTc) ≥470 msec
18 Years
ALL
No
Sponsors
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Ascentage Pharma Group Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yifan Zhai, MD, PhD
Role: STUDY_CHAIR
Ascentage Pharma Group Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Duke University
Durham, North Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APG115AU101
Identifier Type: -
Identifier Source: org_study_id
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