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JNJ-90189892 · 1 trial · 2 indications
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...
JNJ-90189892 is an investigational small molecule developed by Johnson & Johnson for the treatment of acute myeloid leukemia and myelodysplastic neoplasms. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in adults with relapsed or refractory disease.
JNJ-90189892 is being studied for relapsed or refractory acute myeloid leukemia, as well as myelodysplastic neoplasms. It is an investigational therapy and is not approved for any indication. The Phase 1 trial enrolls adults aged 18 years and older, including patients with either condition.
JNJ-90189892 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is running the Phase 1 program for the asset in acute myeloid leukemia and myelodysplastic neoplasms.
JNJ-90189892 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. One Phase 1 trial is currently active, and no trials of the drug have been completed.
JNJ-90189892 is being evaluated in the Phase 1 trial NCT06651229, titled A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms. The trial is active but not recruiting, has an enrollment of 85 participants, and is running in Australia, France, and Spain.