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Trial Title:
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
NCT ID:
NCT06651229
Condition:
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Conditions: Official terms:
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-90189892
Description:
JNJ-90189892 will be administered.
Arm group label:
JNJ-90189892
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 31, 2025
Completion date:
December 1, 2028
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06651229
