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NCT06651229Active, not recruitingPhase 1

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

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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 of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \[RP2CD\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R/R AML (part 3) and newly diagnosed (ND) AML (part 4).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
85 (actual)
First submitted
18 Oct 2024
Start date
21 Mar 2025
Primary completion date
5 Aug 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06651229
EU CT number
2024-514341-10-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 85
  • From 21 Mar 2025 to the primary completion date, 5 Aug 2027
  • 11 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
  • Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment

Other illness

  • Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
  • Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
  • All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients

Other

  • Has known active central nervous system involvement

Who the study is looking for

  • 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 (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria
  • 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) \>=40 milligrams per minute (mL/min) computed with the calculator on the national kidney foundation website
  • Participants must have laboratory parameters in the required range

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Concord Hospital
Coordinator of this site? Confirm its status
ConcordAustraliaUnknown status
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Sir Charles Gairdner Hospital
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceActive, not recruiting
Hopital Saint Louis
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Institut de Cancérologie Strasbourg Europe
Coordinator of this site? Confirm its status
StrasbourgFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
Coordinator of this site? Confirm its status
Strasbourg Cedex 2FranceActive, not recruiting
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.