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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
1. relapsed/refractory acute myeloid leukemia (AML)
2. 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 Criteria:
* 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
Primary outcome measure(s)
Number of Participants with Adverse events (AEs) by Severity — From screening untill 30 days after last dose of study drug (that is approximately 2.5 years) An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs) — 14 days Participants with dose-limiting toxicity (DLT) will be assessed. DLT is defined as any toxicity that requires discontinuation of treatment, any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4) and Hematologic Toxicity.
Trial sites (9)
Facility
City
Region
Status
Arthur J E Child Comprehensive Cancer Centre
Calgary
Alberta
Vancouver General Hospital
Vancouver
British Columbia
Princess Margaret Hospital
Toronto
Ontario
Hosp Clinic de Barcelona
Barcelona
Spain
Hosp Univ Fund Jimenez Diaz
Madrid
Spain
Clinica Univ. de Navarra
Pamplona
Spain
Addenbrookes Hospital
Cambridge
United Kingdom
University College London Hospitals
London
United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester
United Kingdom
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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