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
Janssen Research & Development, LLC
100 participants
Mar 21, 2025
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 (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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
JNJ-90189892 will be administered.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06651229