A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS \[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\]). 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

Trial Details

NCT ID
NCT06651229
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • JNJ-90189892
  • Azacitadine (AZA)
  • Venetoclax (VEN)
Locations (sample)
  • Concord, Australia|-33.84722,151.10381
  • Melbourne, Australia|-37.814,144.96332
  • Nedlands, Australia|-31.98184,115.8073
  • Marseille, France|43.29695,5.38107
  • Strasbourg, France|48.58392,7.74553

Key Eligibility Criteria

  • A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia…
  • Body weight that is greater than or equals to (\>=) 40 kg
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) \>=…

For full eligibility, visit ClinicalTrials.gov.

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