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RECRUITING
NCT06651229
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

DRUG

JNJ-90189892

JNJ-90189892 will be administered.

DRUG

Azacitadine (AZA)

AZA will be administered.

DRUG

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