Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06651229 | NOT YET RECRUITING | Leukemia, Myeloid, Acute

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

Janssen Research & Development, LLC

Brief Summary:

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 (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.

Condition or disease

Leukemia, Myeloid, Acute

Myelodysplastic Neoplasms

Intervention/treatment

JNJ-90189892

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Actual Study Start Date : 2025-03-31
Estimated Primary Completion Date : 2027-08-05
Estimated Study Completion Date : 2028-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Location Details

NCT06651229

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found