Health TrialsbyHealthPanel

A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

ConditionsLeukemia, Myeloid, AcuteMyelodysplastic Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS \[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\]). 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 at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \[RP2CD\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R/R AML (part 3) and newly diagnosed (ND) AML (part 4).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria

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 national kidney foundation website

Disqualifiers

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

All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients

Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892

Trial design

Design model

Sequential

Treatments tested in this trial

  • JNJ-90189892

    Drug

    JNJ-90189892 will be administered.

  • Azacitadine (AZA)

    Drug

    AZA will be administered.

  • Venetoclax (VEN)

    Drug

    VEN will be administered.

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: JNJ-90189892: MonotherapyExperimental treatment 1 intervention
Group B: JNJ-90189892: In Combination with Azacitadine (AZA)+ Venetoclax (VEN)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)
2

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

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
At least 14 days

Secondary outcomes

1

Serum Concentration of JNJ-90189892

Serum samples will be analyzed to determine concentrations of JNJ-90189892.

Time frame
Up to approximately 2.5 years
2

Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892

AUC tau is the total observed plasma concentration of JNJ-90189892 in the body during the time between doses. AUCtau of JNJ-90189892 will be reported.

Time frame
Up to approximately 2.5 years
3

Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892

Cmax is the maximum observed plasma concentration of JNJ-90189892. Cmax of JNJ-90189892 will be reported.

Time frame
Up to approximately 2.5 years
4

Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892

Cmin is the minimum observed plasma concentration of JNJ-90189892. Cmin of JNJ-90189892 will be reported.

Time frame
Up to approximately 2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
Apply now