Actively Recruiting
A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)
Led by Apollo Therapeutics Ltd · Updated on 2026-06-01
100
Participants Needed
9
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a drug called APL-4098 alone and combined with azacitidine, and with azacitidine plus venetoclax. This study focuses on adults with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML, or MDS with excess blasts. The trial is an open-label Phase 1 study designed to find appropriate dosing and assess treatment effects in these blood cancers. The study includes different treatment groups where participants receive escalating doses of APL-4098 alone, APL-4098 combined with azacitidine, or APL-4098 combined with azacitidine and venetoclax. Azacitidine is given at a standard dose during the first seven days of each 28-day treatment cycle, while APL-4098 and venetoclax are taken orally. Participants may receive these treatments in cycles lasting 28 days, with dose levels adjusted during the escalation phase. Participants will be closely monitored throughout the study, including for side effects and drug levels in the body on specific days of treatment cycles. Researchers will assess safety through adverse event tracking and dose-limiting toxicities during the first cycles. They will also evaluate how the disease responds to treatment at several points up to two years. The study is expected to last approximately one year for primary safety and dosing outcomes, with longer follow-up for treatment response.
CONDITIONS
Brief 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 specific characteristics including intolerance or ineligibility for available therapies
- White blood cell count less than or equal to 25,000 per microliter
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Weight at least 40 kilograms
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use specific contraception or avoid intercourse during the study
- Male participants must agree to use specific contraception and not plan to impregnate a partner 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 of Cycle 1 Day 1
- Received prior radiation therapy within 4 weeks of screening
- History of other malignancies
- Myocardial infarction within 6 months of screening
- Symptomatic congestive heart failure
- Uncontrolled active infection
- History of arterial thrombosis within 6 months of screening
- Left ventricular ejection fraction less than 45%
- Fridericia's corrected QT interval greater than 470 milliseconds
- 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 (adjusted for females)
- HIV positive
- Active hepatitis B or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive APL-4098 alone or in combination with azacitidine and/or venetoclax in 28-day cycles to assess safety and antitumor activity.
Visits on Days 1, 2, 8, and 15 of Cycle 1, Day 1 of Cycle 2, and response assessments at Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, then every three cycles thereafter
Trial Site Locations
Total: 9 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
Active, Not Recruiting
5
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
6
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
7
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G120YN
Actively Recruiting
8
The Royal Marsden Hospital
London, United Kingdom, SM2 5PT
Actively Recruiting
9
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 0PU
Actively Recruiting
Research Team
A
Apollo Therapeutics
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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