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

NCT06372717 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-04

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

APL-4098

APL-4098 is administered orally in 28-day cycles

DRUG

Azacitidine and APL-4098

Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally.

DRUG

Azacitidine and Venetoclax and APL-4098

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.

Sponsors & Collaborators

  • Apollo Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Sanjay Aggarwal, MD · Apollo Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2027-03-01
Completion
2027-05-01

Countries

  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372717 on ClinicalTrials.gov