MedTrace Logo

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

NCT06651229 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-05-08

No results posted yet for this study

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 (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).

Conditions

  • Leukemia, Myeloid, Acute
  • Myelodysplastic Neoplasms

Interventions

DRUG

JNJ-90189892

JNJ-90189892 will be administered.

DRUG

Azacitadine (AZA)

AZA will be administered.

DRUG

Venetoclax (VEN)

VEN will be administered.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2027-08-05
Completion
2028-11-21
FDA Drug
Yes

Countries

  • Australia
  • France
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06651229 on ClinicalTrials.gov