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Bioavailability and Bioequivalence Study of Ziftomenib in Participants With Relapsed/Refractory AML or MDS

5. november 2026 oppdatert av: Kura Oncology, Inc.

Relative Bioavailability and Bioequivalence Study of Ziftomenib Drug Products in Participants With Relapsed/Refractory AML With NPM1 Mutation, or With Relapsed/Refractory AML or MDS With Mutations Associated With MEIS1 Overexpression

This study will evaluate the pharmacokinetics (PK) of ziftomenib drug products to inform relative bioavailability (rBA) and bioequivalence (BE) assessments.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to measure rBA or BE of various ziftomenib drug products in participants with R/R NPM1-m AML, or with R/R AML or MDS with a mutation associated with MEIS1 overexpression.

Study details include:

  • The study is composed of two parts.
  • Participant study duration will be a minimum of approximately 4 months including screening, 2 cycles of treatment, and safety follow-up.
  • The visit frequency will be weekly in Part 1.
  • The required treatment duration will be approximately 2 cycles of treatment (56 days) in Part 1 with the option for participants deriving clinical benefit to continue treatment in Part 2.
  • The visit frequency will be monthly in Part 2.

Studietype

Intervensjonell

Registrering (Antatt)

126

Fase

  • Fase 1

Utvidet tilgang

Tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years.
  2. Relapsed/refractory NPM1-mutated AML, or relapsed/refractory AML or MDS with a mutation associated with MEIS1 overexpression; disease confirmed in blood and/or bone marrow, as applicable, and not a candidate for currently approved standard-of-care regimens or hematopoietic stem cell transplantation (HSCT).
  3. Female participants must not be pregnant or breastfeeding.
  4. Male participants with partners of childbearing potential must agree to abstinence or highly effective contraception and refrain from sperm donation during treatment and for at least 90 days after the last dose.
  5. Signed informed consent.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and life expectancy ≥2 months.
  7. Adequate organ function: estimated glomerular filtration rate ≥30 mL/min/1.73 m²; bilirubin ≤1.5 × the upper limit of normal (ULN), unless attributable to Gilbert's syndrome or leukemic disease; and AST and ALT ≤3 × ULN.
  8. Peripheral white blood cell count ≤25,000/µL before Day 1 of Part 1; hydroxyurea or cytarabine may be used to control the count.

Exclusion Criteria:

  1. Clinically active central nervous system (CNS) leukemia; participants with controlled CNS leukemia receiving intrathecal therapy at study entry may be eligible.
  2. Grade ≥2 acute graft-versus-host disease (GVHD), moderate/severe limited chronic GVHD, or extensive chronic GVHD.
  3. Active HIV, hepatitis C, or hepatitis B infection, as defined in the protocol; participants with controlled disease are not excluded.
  4. Active, uncontrolled systemic fungal, bacterial, viral, or other infection.
  5. Significant cardiovascular disease, including unstable angina, uncontrolled hypertension or arrhythmia, qualifying heart failure, ischemic or severe valvular heart disease, or stroke, transient ischemic attack, or myocardial infarction within the preceding 6 months.
  6. Mean QT interval corrected using Fridericia's formula (QTcF) >480 ms on triplicate electrocardiograms obtained within 5 minutes of each other.

The full inclusion and exclusion criteria, including applicable definitions are presented in the study protocol.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort A

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)
Legemiddel: Ziftomenib

Oral Formulation 1

Legemiddel: Ziftomenib

Oral Formulation 2

Legemiddel: Ziftomenib

Oral Formulation 3

Legemiddel: Ziftomenib

Oral Formulation 4
Eksperimentell: Cohort B

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)
Legemiddel: Ziftomenib

Oral Formulation 1

Legemiddel: Ziftomenib

Oral Formulation 2

Legemiddel: Ziftomenib

Oral Formulation 3

Legemiddel: Ziftomenib

Oral Formulation 4
Eksperimentell: Cohort C

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)
Legemiddel: Ziftomenib

Oral Formulation 1

Legemiddel: Ziftomenib

Oral Formulation 2

Legemiddel: Ziftomenib

Oral Formulation 3

Legemiddel: Ziftomenib

Oral Formulation 4

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
Tidsramme: During the first 56 days of ziftomenib

Maximum plasma concentration at steady state (Cmax,ss)
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib

Plasma concentration observed at end of dosing interval at steady state (Cτ)
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
Tidsramme: During the first 56 days of ziftomenib

Area under the concentration-time curve from time 0 to dosing interval at steady state (AUC0-τ,ss)
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib

Time to Cmax,ss (Tmax,ss)
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib

Cavg,ss
During the first 56 days of ziftomenib

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib

Cτ
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib

Tmax,ss
During the first 56 days of ziftomenib
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib

Cavg,ss
During the first 56 days of ziftomenib
To assess safety and tolerability of ziftomenib (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose
  1. Incidence and severity of AEs per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) V6.0
  2. Incidence of SAEs
Day 1 of study intervention through 28 days after the last dose
To assess discontinuation of study treatment due to Adverse Events (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose

Discontinuation of study treatment due to AEs
Day 1 of study intervention through 28 days after the last dose
To assess deaths while receiving treatment (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose

Deaths on treatment
Day 1 of study intervention through 28 days after the last dose

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kura Oncology, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. oktober 2026

Primær fullføring (Antatt)

28. februar 2029

Studiet fullført (Antatt)

28. februar 2029

Datoer for studieregistrering

Først innsendt

21. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KO-MEN-018
  • 2025 (U.S. NIH-stipend/kontrakt)
  • 2025-524332-19-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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