Clinical trial NCT06618001: A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 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: 2024-10-01
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 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 criteria: 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 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: 14 days
Secondary outcomes:
measure: Serum Concentration of JNJ- 89853413
timeFrame: Approximately 2.5 years
measure: Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413
timeFrame: Approximately 2.5 years
measure: Maximum Serum Concentration (Cmax) of JNJ-89853413
timeFrame: Approximately 2.5 years
measure: Trough Observed Serum Concentration (Ctrough) of JNJ-89853413
timeFrame: Approximately 2.5 years
measure: Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413
timeFrame: Approximately 2.5 years
measure: Complete Response (CR) in Acute Myeloid Leukemia (AML)
timeFrame: Approximately 2.5 years
measure: Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
timeFrame: Approximately 2.5 years
measure: Complete Response in MDS
timeFrame: Approximately 2.5 years
measure: Duration of Response (DOR)
timeFrame: Approximately 2.5 years
measure: Time to response (TTR)
timeFrame: Approximately 2.5 years
measure: Number of Participants Achieving Transfusion independence
timeFrame: Approximately 2.5 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: London
country: United Kingdom
facility: University College London Hospitals
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust Christie Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: