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MDM2 Inhibitor

APG-115 + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function including liver function (total bilirubin ≤ 1.5 x upper limit of normal, AST and/or ALT < 3 x ULN), kidney function (calculated creatinine clearance ≥ 60 mL/min), known cardiac ejection fraction of ≥ 45% within the past 3 months, ECOG performance status of ≤ 2
Patients with a diagnosis of histologically confirmed relapsed or refractory AML, CMML, or high-risk MDS by World Health Organization (WHO) classification
Must not have
Prior systemic MDM2-p53 inhibitor treatment
Failure to have recovered (Grade > 1) from prior treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, APG-115, to see if it is safe and effective in treating patients with relapsed or refractory leukemia.

Who is the study for?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high-risk myelodysplastic syndrome (MDS). Participants must have a life expectancy of at least 12 weeks, adequate organ function, an ECOG performance status of ≤2, and no severe allergies to the treatments. Pregnant women and those not using contraception are excluded.
What is being tested?
The study examines APG-115 alone or combined with Azacitidine in patients with certain blood cancers. Initially, it will assess the safety of APG-115 as a single agent; then it will test the combination therapy's effectiveness against these diseases.
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, issues from uncontrolled infections like hepatitis B/C or HIV, heart problems such as congestive heart failure or arrhythmias, and complications related to recent stem cell transplants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver, kidneys, and heart are functioning well, and I can care for myself.
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My condition is a type of blood cancer that has come back or didn’t respond to treatment.
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No standard treatments are expected to work long-term for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously received treatment targeting the MDM2-p53 pathway.
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I still have significant side effects from my previous treatment.
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I am of childbearing age and not using birth control.
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I have active leukemia in my brain that is not under control.
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I have had a stem cell transplant within the last year and may still be on immunosuppressive drugs.
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I do not have an active infection needing antibiotics, or active hepatitis B/C, or HIV.
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I have been diagnosed with acute promyelocytic leukemia.
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I do not have any severe illnesses or heart problems that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: APG-115 monotherapyExperimental Treatment1 Intervention
Monotherapy given in part 1
Group II: APG-115 + 5-azacitidine combinationExperimental Treatment2 Interventions
Combination therapy given in part 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APG-115
2016
Completed Phase 1
~50
5-azacitidine
2008
N/A
~30

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
52 Previous Clinical Trials
5,598 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,292 Total Patients Enrolled

Media Library

APG-115 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04358393 — Phase 1 & 2
~1 spots leftby Dec 2024
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