A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Phase 1Active Not RecruitingNCT06618001

Janssen Research & Development, LLC64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Acute Myelodysplastic Neoplasms

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

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

Outcomes

Primary Outcomes

Number of Participants with Adverse events (AEs) by Severity

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.

Time frame: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)

Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)

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.

Time frame: 14 days

Secondary Outcomes

Serum Concentration of JNJ- 89853413

Serum samples will be analyzed to determine concentrations of JNJ-89853413 using a validated immunoassay method.