A Phase I, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Study Identifier:
89853413AML1001
CT.gov Identifier:
NCT06618001
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-513199-16-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose\[s\] (RP2D\[s\]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Leukemia
  • Myeloid
  • Myelodysplastic Syndrome
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: JNJ-89853413
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  • Drug: Intervention/Treatment
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
    • 1. relapsed/refractory acute myeloid leukemia (AML)
    • 2. relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
    • * Body weight greater than or equals to (\>=) 40 kilograms (kg)
    • * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
    • * Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \>=40 milligrams per minute (mL/min)
    • * Participants must have laboratory parameters in the required range
    Exclusion criteria
    • * Has a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation
    • * Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
    • * Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413
    • * Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
    • * Has known active central nervous system involvement

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Daniel Morillo Giles
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Leukemia
    Myeloid
    Myelodysplastic Syndrome