Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 89853413AML1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2024-513199-16-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-89853413 | Experimental | Participants will receive JNJ-89853413 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89853413 at the RP2D determined in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-89853413 | Drug | JNJ-89853413 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ- 89853413 | Serum samples will be analyzed to determine concentrations of JNJ-89853413 using a validated immunoassay method. | Approximately 2.5 years |
| Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413 |
Not provided
Inclusion Criteria:
Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada | ||
| Vancouver General Hospital |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.
| Approximately 2.5 years |
| Maximum Serum Concentration (Cmax) of JNJ-89853413 | Cmax is defined as maximum serum concentration of JNJ-89853413. | Approximately 2.5 years |
| Trough Observed Serum Concentration (Ctrough) of JNJ-89853413 | Ctrough is the trough observed serum concentration of JNJ-89853413. | Approximately 2.5 years |
| Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413 | Participants with anti JNJ-89853413 antibodies will be analyzed by a bridging electrochemiluminescence (ECL) enzyme linked immune assay. | Approximately 2.5 years |
| Complete Response (CR) in Acute Myeloid Leukemia (AML) | 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. | Approximately 2.5 years |
| Overall Response (OR) in Myelodysplastic Neoplasms (MDS) | 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. | Approximately 2.5 years |
| Complete Response in MDS | CR is achieved when a participant has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria. | Approximately 2.5 years |
| Duration of Response (DOR) | 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. | Approximately 2.5 years |
| Time to response (TTR) | TTR is defined for responders only, as the time from the first dose of study drug to first qualifying response. | Approximately 2.5 years |
| Number of Participants Achieving Transfusion independence | 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. | Approximately 2.5 years |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2C1 | Canada |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Addenbrookes Hospital | Cambridge | Cb2 2qq | United Kingdom |
| University College London Hospitals | London | W1T 7HA | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided