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

Sponsor
Apollo Therapeutics Ltd
Study ID
NCT06372717
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)
  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse
  • Myelodysplastic Syndrome Acute Myeloid Leukemia
  • Myelodysplastic Syndrome With Excess Blasts

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APL-4098 — DRUG
    APL-4098 is administered orally in 28-day cycles
  • Azacitidine and APL-4098 — DRUG
    Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally.
  • Azacitidine and Venetoclax and APL-4098 — DRUG
    Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; Venetoclax is administered orally; APL-4098 is administered orally.

Study Details

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).

Key Dates

Start date
Jun 4, 2024
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase: APL-4098 monotherapy
    Dose escalation with different dosing levels of APL-4098.
  • Experimental: Dose Escalation Phase: APL-4098 and azacitidine
    Dose escalation with different dosing levels of APL-4098 in combination with azacitidine.
  • Experimental: APL-4098 and azacitidine and venetoclax
    Dose escalation with different dosing levels of APL-4098 in combination with azacitidine and venetoclax.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events [Safety] [ Time Frame: Through study completion, approximately one year ]

Central Contacts

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