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OncoMatch/Clinical Trials/NCT06372717

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

Is NCT06372717 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including APL-4098 and Azacitidine and APL-4098 for acute myeloid leukemia refractory.

Phase 1RecruitingApollo Therapeutics LtdNCT06372717Data as of Jun 2026Location: Australia · United Kingdom

Treatment: APL-4098 · Azacitidine and APL-4098 · Azacitidine and Venetoclax and APL-4098This 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).

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Extracted eligibility criteria

Treatments studied

Other

APL-4098Azacitidine and APL-4098Azacitidine and Venetoclax and APL-4098

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: allogeneic stem cell transplant

received an allogeneic stem cell transplant within 6 months of screening

Cannot have received: autologous stem cell transplant

received an autologous stem cell transplant within 3 months of screening

Cannot have received: anti-cancer treatments

received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1

Cannot have received: radiation therapy

prior radiation therapy within 4 weeks of screening

Lab requirements

Blood counts

WBC count ≤ 25,000/microliter

Kidney function

calculated or measured creatinine clearance ≥ 45 mL/minute (multiply by 0.85 if female)

Liver function

Aspartate aminotransferase and/or alanine aminotransferase ≤ 3 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN

Cardiac function

Left ventricular ejection fraction ≥ 45%, Fridericia's corrected QT interval ≤ 470msec

WBC count ≤ 25,000/microliter; 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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06372717 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic stem cell transplant, autologous stem cell transplant, anti-cancer treatments disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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