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

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

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

Inclusion Criteria8

years or older
Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.
WBC count ≤ 25,000/microliter
ECOG Performance Status of ≤ 2
Weight ≥ 40kg
Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study
Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial

Exclusion Criteria4

Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening
Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening
Diagnostic assessments: 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)
Infectious disease: HIV positive, active hepatitis B and/or C

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.