Clinical trial NCT06651229: A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of Participants with Adverse events (AEs) by Severity
timeFrame: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)
measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
timeFrame: At least 14 days
Secondary outcomes:
measure: Serum Concentration of JNJ-90189892
timeFrame: Up to approximately 2.5 years
measure: Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892
timeFrame: Up to approximately 2.5 years
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892
timeFrame: Up to approximately 2.5 years
measure: Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892
timeFrame: Up to approximately 2.5 years
measure: Number of Participants with Presence of Anti-JNJ-90189892 Antibodies
timeFrame: Up to approximately 2.5 years
measure: Complete Response (CR) in Acute Myeloid Leukemia (AML)
timeFrame: Up to approximately 2.5 years
measure: Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
timeFrame: Up to approximately 2.5 years
measure: Complete Response in MDS
timeFrame: Up to approximately 2.5 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2.5 years
measure: Time to Response (TTR)
timeFrame: Up to approximately 2.5 years
measure: Number of Participants Achieving Transfusion Independence
timeFrame: Up to approximately 2.5 years
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: