Tests APL-4098 alone and with other drugs in adults with blood cancers
Tests APL-4098, alone or with azacitidine, in adults with acute myeloid leukemia or MDS.
Plain-language title generated from the registry record
Registry title: A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
Key facts
- Where
- Cardiff, Glasgow, and London, United KingdomSee the 4 sites
- Phase
- Phase 1
Where in United Kingdom
- University Hospital of WalesCardiff, United KingdomTaking people
- Beatson West of Scotland Cancer CentreGlasgow, United KingdomTaking people
- Sarah Cannon Research Institute UKLondon, United KingdomTaking people
- The Royal Marsden HospitalLondon, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Apollo Therapeutics Ltd
- Trial code
- NCT06372717
- Record updated
- 28 October 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 18 years or older; Confirmed diagnosis of acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit; Newly diagnosed (ND AML), previously untreated, and considered unfit for available front line therapies or standard intensive chemotherapy; WBC count ≤ 25,000/microliter; ECOG Performance Status of ≤ 2; Weight ≥ 40kg; Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse; Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study; Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial.
Exclusion: Certain prior therapies such as: 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, prior radiation therapy within 4 weeks of screening; Certain medical conditions such as: 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; Infectious disease: HIV positive, active hepatitis B and/or C; Diagnostic assessments: Left ventricular ejection fraction < 45%, Fridericia's corrected QT interval > 470msec, Aspartate aminotransferase and/or alanine aminotransferase > 3 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN, calculated or measured creatinine clearance < 45 mL/minute (multiply by 0.85 if female).