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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Neoplasms

Treatments: Drug: JNJ-90189892

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651229

90189892AML1001

2024-514341-10-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 1 patient group

JNJ-90189892

Experimental group

Description:

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.

Treatment:

Drug: JNJ-90189892