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NCT06372717 · ClinicalTrials.gov record · last posted 2026-06-01

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

StatusRecruiting
PhasePhase 1
Started2024-06-04
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from the ClinicalTrials.gov record
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).

Amendment record 7 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 7 times since 2024-04-15; most recent amendment 2026-05-29. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-07-08
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06372717
Lead Sponsor Apollo Therapeutics Ltd
Conditions Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia (AML)
Enrollment 100 participants
Start Date 2024-06-04
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-01