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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06651229




Registration number
NCT06651229
Ethics application status
Date submitted
18/10/2024
Date registered
21/10/2024

Titles & IDs
Public title
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Scientific title
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Secondary ID [1] 0 0
90189892AML1001
Secondary ID [2] 0 0
90189892AML1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Myelodysplastic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-90189892

Experimental: JNJ-90189892 - Participants will receive JNJ-90189892 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-90189892 at the RP2D determined in Part 1.


Treatment: Drugs: JNJ-90189892
JNJ-90189892 will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse events (AEs) by Severity
Timepoint [1] 0 0
From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)
Primary outcome [2] 0 0
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
Timepoint [2] 0 0
At least 14 days
Secondary outcome [1] 0 0
Serum Concentration of JNJ-90189892
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [2] 0 0
Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892
Timepoint [2] 0 0
Up to approximately 2.5 years
Secondary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892
Timepoint [3] 0 0
Up to approximately 2.5 years
Secondary outcome [4] 0 0
Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892
Timepoint [4] 0 0
Up to approximately 2.5 years
Secondary outcome [5] 0 0
Number of Participants with Presence of Anti-JNJ-90189892 Antibodies
Timepoint [5] 0 0
Up to approximately 2.5 years
Secondary outcome [6] 0 0
Complete Response (CR) in Acute Myeloid Leukemia (AML)
Timepoint [6] 0 0
Up to approximately 2.5 years
Secondary outcome [7] 0 0
Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
Timepoint [7] 0 0
Up to approximately 2.5 years
Secondary outcome [8] 0 0
Complete Response in MDS
Timepoint [8] 0 0
Up to approximately 2.5 years
Secondary outcome [9] 0 0
Duration of Response (DOR)
Timepoint [9] 0 0
Up to approximately 2.5 years
Secondary outcome [10] 0 0
Time to Response (TTR)
Timepoint [10] 0 0
Up to approximately 2.5 years
Secondary outcome [11] 0 0
Number of Participants Achieving Transfusion Independence
Timepoint [11] 0 0
Up to approximately 2.5 years

Eligibility
Key inclusion criteria
* Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Acute myeloid leukemia (AML) or (b) Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
* Body weight that is greater than or equals to (>=) 40 kg
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 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) computed with the calculator on the CKD-EPI website
* Participants must have laboratory parameters in the required range
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
* Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
* Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients
* Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
* Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Has known active central nervous system involvement

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06651229