Actively Recruiting
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
Led by Apollo Therapeutics Ltd · Updated on 2026-02-04
100
Participants Needed
7
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).
CONDITIONS
Official Title
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/AML, or MDS-excess blasts (MDS-EB) with R/R AML (primary or secondary, including treatment-related), intolerant or ineligible for available beneficial therapies
- White blood cell count (WBC) of 25,000/microliter or less
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Weight of 40 kilograms or more
- Female participants of childbearing potential must have a negative serum pregnancy test at screening, not plan to become pregnant, harvest ova, or breastfeed during the study, and agree to use specific contraception or avoid intercourse
- Male participants must agree to use specific contraception and not plan to father a child or donate sperm during the study
- Willing and able to provide written informed consent and comply with study requirements
You will not qualify if you...
- Received an allogeneic stem cell transplant within 6 months of screening
- Received an autologous stem cell transplant within 3 months of screening
- Received any anti-cancer treatments within 2 weeks before Cycle 1 Day 1
- Received prior radiation therapy within 4 weeks of screening
- Have other malignancies
- Had myocardial infarction within 6 months of screening
- Have symptomatic congestive heart failure
- Have uncontrolled active infection
- Had arterial thrombosis within 6 months of screening
- Left ventricular ejection fraction less than 45%
- Fridericia's corrected QT interval greater than 470 msec
- Aspartate aminotransferase and/or alanine aminotransferase greater than 3 times the upper limit of normal
- Total bilirubin greater than 1.5 times the upper limit of normal
- Calculated or measured creatinine clearance less than 45 mL/minute (multiply by 0.85 if female)
- HIV positive
- Active hepatitis B and/or C infection
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
2
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
3
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
4
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
5
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
6
The Royal Marsden Hospital
London, United Kingdom, SM2 5PT
Actively Recruiting
7
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 0PU
Actively Recruiting
Research Team
A
Apollo Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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