RecruitingPhase 1NCT06651229

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


Sponsor

Janssen Research & Development, LLC

Enrollment

155 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JNJ-90189892 in patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) — blood cancers that have stopped responding to previous treatments. This is an early-phase trial focused on finding the right dose and assessing safety. **You may be eligible if...** - You have been diagnosed with AML or high/very high-risk MDS - Your disease has come back or is no longer responding to treatment - You weigh at least 40 kg - You are in reasonable physical condition (ECOG 0–2) - Your kidney and blood lab values meet minimum thresholds **You may NOT be eligible if...** - Your disease is newly diagnosed and untreated - Your kidney function is significantly impaired - You have serious uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-90189892

JNJ-90189892 will be administered.

DRUGAzacitadine (AZA)

AZA will be administered.

DRUGVenetoclax (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

View Full Details on ClinicalTrials.gov

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NCT06651229


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