A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Janssen Research & Development, LLC
115 participants
Jan 14, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose\[s\] (RP2D\[s\]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). 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 Criteria7
- Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
- relapsed/refractory acute myeloid leukemia (AML)
- relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
- Body weight greater than or equals to (\>=) 40 kilograms (kg)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 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)
- Participants must have laboratory parameters in the required range
Exclusion Criteria5
- Has a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation
- Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
- Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413
- Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
- Has known active central nervous system involvement
Interventions
JNJ-89853413 will be administered.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06618001