NCT06372717 A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
| NCT ID | NCT06372717 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Apollo Therapeutics Ltd |
| Condition | Acute Myeloid Leukemia Refractory |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-06-04 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 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. * 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 Criteria: * 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 * 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) * Infectious disease: HIV positive, active hepatitis B and/or C
Contact & Investigator
Sanjay Aggarwal, MD
STUDY CHAIR
Apollo Therapeutics
Frequently Asked Questions
Who can join the NCT06372717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia Refractory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06372717 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06372717 currently recruiting?
Yes, NCT06372717 is actively recruiting participants. Contact the research team at AP30@apollotx.com for enrollment information.
Where is the NCT06372717 trial being conducted?
This trial is being conducted at Clayton, Australia, Fitzroy, Australia, Melbourne, Australia, Nedlands, Australia and 5 additional locations.
Who is sponsoring the NCT06372717 clinical trial?
NCT06372717 is sponsored by Apollo Therapeutics Ltd. The principal investigator is Sanjay Aggarwal, MD at Apollo Therapeutics. The trial plans to enroll 100 participants.
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