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

NCT ID: NCT06651229

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2028-12-01

Brief Summary

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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 (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.

Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Myelodysplastic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-90189892

Participants will receive JNJ-90189892 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the study evaluation team (SET) until the recommended phase 2 dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-90189892 at the RP2D determined in Part 1.

Group Type EXPERIMENTAL

JNJ-90189892

Intervention Type DRUG

JNJ-90189892 will be administered.

Interventions

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JNJ-90189892

JNJ-90189892 will be administered.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Acute myeloid leukemia (AML) or (b) Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
* 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 CKD-EPI website
* Participants must have laboratory parameters in the required range

Exclusion Criteria

* 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
* Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients
* 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
* Has known active central nervous system involvement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Concord Hospital

Concord, , Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, , Australia

Site Status RECRUITING

Sir Charles Gairdner Hospital

Nedlands, , Australia

Site Status RECRUITING

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, , France

Site Status RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Rocio

Seville, , Spain

Site Status RECRUITING

Countries

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Australia France Spain

Central Contacts

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Study Contact

Role: CONTACT

844-434-4210

Other Identifiers

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90189892AML1001

Identifier Type: OTHER

Identifier Source: secondary_id

2024-514341-10-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

90189892AML1001

Identifier Type: -

Identifier Source: org_study_id

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