A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS

A

Apollo Therapeutics

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Acute Myeloid Leukemia Refractory
Myelodysplastic Syndrome With Excess Blasts
Myelodysplastic Syndrome Acute Myeloid Leukemia
Acute Myeloid Leukemia, in Relapse

Treatments

Drug: APL-4098
Drug: Azacitidine and APL-4098

Study type

Interventional

Funder types

Industry

Identifiers

NCT06372717
AP30CP01

Details and patient eligibility

About

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 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 we 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 criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

112 participants in 4 patient groups

Dose Escalation Phase: APL-4098 monotherapy
Experimental group
Description:
Dose escalation with different dosing levels of APL-4098.
Treatment:
Drug: APL-4098
Dose Escalation Phase: APL-4098 and azacitidine
Experimental group
Description:
Dose escalation with different dosing levels of APL-4098 in combination with azacitidine (75 mg/m2).
Treatment:
Drug: Azacitidine and APL-4098
Phase 2 Dose Expansion: APL-4098 monotherapy
Experimental group
Treatment:
Drug: APL-4098
Phase 2 Dose Expansion: APL-4098 and azacitidine
Experimental group
Treatment:
Drug: Azacitidine and APL-4098

Trial contacts and locations

0

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Central trial contact

Apollo Therapeutics

Data sourced from clinicaltrials.gov

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