Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06651229 | A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms | PHASE1 | RECRUITING | 155 | — | — | Mar 21, 2025 | Nov 21, 2028 | Jun 5, 2026 | 9 | Australia, France +1 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| JNJ-90189892: Monotherapy | EXPERIMENTAL | 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. |
| JNJ-90189892: In Combination with Azacitadine (AZA)+ Venetoclax (VEN) | EXPERIMENTAL | Participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) in Part 3 will receive JNJ-90189892+ AZA+VEN to determine the recommended Phase 2 combination dose (RP2CD). The starting JNJ-90189892 dose regimen in Part 3 will be at least 1 dose level below the highest dose level cleared in Part 1 as determined by the SET. In Part 4 participants with newly diagnosed (ND) AML will receive JNJ-90189892+ AZA+VEN starting from the JNJ-90189892 dose level determined safe in Part 3 by the SET. |
| Name | Type | Description |
|---|---|---|
| JNJ-90189892 | DRUG | JNJ-90189892 will be administered. |
| Azacitadine (AZA) | DRUG | AZA will be administered. |
| Venetoclax (VEN) | DRUG | VEN will be administered. |
Inclusion Criteria: * 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 Pr...