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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 being developed for the treatment of acute myeloid leukemia and myelodysplastic neoplasms. It is currently being studied in patients with relapsed or refractory disease, meaning the cancer has returned or has not responded to prior treatment.
JNJ-90189892 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development.
JNJ-90189892 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.
JNJ-90189892 is being studied in a Phase 1 clinical trial with the identifier NCT06651229. This trial is recruiting patients with relapsed or refractory acute myeloid leukemia or myelodysplastic neoplasms and has an estimated enrollment of 155 participants across Australia, France, and Spain.
No alternative names for JNJ-90189892 have been disclosed. The drug is identified solely by its investigational code JNJ-90189892 in the clinical trial registry.