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A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Sponsor: Janssen Research & Development, LLC
Summary
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).
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2025-03-21
Completion Date
2028-11-21
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
JNJ-90189892
JNJ-90189892 will be administered.
Azacitadine (AZA)
AZA will be administered.
Venetoclax (VEN)
VEN will be administered.
Locations (9)
Concord Hospital
Concord, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Institut Paoli-Calmettes
Marseille, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hospital Universitario Virgen Rocio
Seville, Spain