Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms
Conditions
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.
Interventions
DRUGJNJ-89853413
JNJ-89853413 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of JNJ- 89853413 | Approximately 2.5 years | Serum samples will be analyzed to determine concentrations of JNJ-89853413 using a validated immunoassay method. |
| Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413 | Approximately 2.5 years | AUC\[t\] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state. |
| Maximum Serum Concentration (Cmax) of JNJ-89853413 | Approximately 2.5 years | Cmax is defined as maximum serum concentration of JNJ-89853413. |
| Trough Observed Serum Concentration (Ctrough) of JNJ-89853413 | Approximately 2.5 years | Ctrough is the trough observed serum concentration of JNJ-89853413. |
| Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413 | Approximately 2.5 years | Participants with anti JNJ-89853413 antibodies will be analyzed by a bridging electrochemiluminescence (ECL) enzyme linked immune assay. |
| Complete Response (CR) in Acute Myeloid Leukemia (AML) | Approximately 2.5 years | CR is achieved when a participant has a best response of CR (complete response with partial hematologic recovery \[CRh\] or complete response with incomplete hematologic recovery \[CRi\]) according to the European Leukemia Network (ENL) 2022 criteria. |
| Overall Response (OR) in Myelodysplastic Neoplasms (MDS) | Approximately 2.5 years | OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery \[CRL\]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria. |
| Complete Response in MDS | Approximately 2.5 years | CR is achieved when a participant has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria. |
| Duration of Response (DOR) | Approximately 2.5 years | DOR is defined for responsders only, as time from date of initial documentation of a response to the first documented evidence of no reponse, disease progression, relapse, initation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant \[HSCT\]), or death, whichever comes first. |
| Time to response (TTR) | Approximately 2.5 years | TTR is defined for responders only, as the time from the first dose of study drug to first qualifying response. |
| Number of Participants Achieving Transfusion independence | Approximately 2.5 years | Transfusion independence is defined as the absence of red blood cell (RBC) and platelet transfusions for 8 weeks or longer after starting study treatment for participants with AML and 16 weeks or longer for participants with MDS. |
Countries
Canada, Spain, United Kingdom
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed