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A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Clinicaltrials.gov:
EU CTIS:
#2024-514341-10-00
Other:
#90189892AML1001
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Trials at a glance
Status
Enrolling
Condition
Leukemia, Myeloid, Acute
Myelodysplastic Neoplasms
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
Azacitadine (AZA)
JNJ-90189892
Venetoclax (VEN)
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
March 21, 2025
Trial end date
November 21, 2028
CT.gov ID
#NCT06651229
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
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).
Primary outcome measures
- Number of Participants with Adverse events (AEs) by Severity
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
Secondary outcome measures
- Serum Concentration of JNJ-90189892
- Area Under the Curve Over a Dosing Interval (AUC tau) of JNJ-90189892
- Maximum Observed Plasma Concentration (Cmax) of JNJ-90189892
- Minimum Observed Plasma Concentration (Cmin) of JNJ-90189892
- Number of Participants with Presence of Anti-JNJ-90189892 Antibodies
- Complete Response (CR) in Acute Myeloid Leukemia (AML)
- Overall Response (OR) in Myelodysplastic Neoplasms (MDS)
- Complete Response in MDS
- Duration of Response (DOR)
- Time to Response (TTR)
- Number of Participants Achieving Transfusion Independence
- Part 4 Only: Overall Survival (OS)
- Part 4 Only: Event-Free Survival (EFS)
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