RecruitingPhase 1NCT06372717

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

A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)


Sponsor

Apollo Therapeutics Ltd

Enrollment

100 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called APL-4098, both on its own and in combination with other treatments, in adults with hard-to-treat blood cancers — specifically relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory AML or MDS that has not responded to standard treatments or where standard treatments are not an option - Your white blood cell count is not excessively high - Your overall physical condition and organ function meet minimum requirements (ECOG ≤ 2, weight ≥ 40kg) **You may NOT be eligible if...** - Your blood cancer has responded well to available standard therapies - You are pregnant, planning to become pregnant, or breastfeeding (effective contraception required) - Your organ function does not meet minimum thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPL-4098

APL-4098 is administered orally in 28-day cycles

DRUGAzacitidine 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.

DRUGAzacitidine 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.


Locations(7)

Monash Health

Clayton, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

The Royal Marsden Hospital

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06372717


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