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JNJ-89853413 · 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.
Participants with dose-limiting toxicity (DLT) will be assessed. 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-89853413 | EXPERIMENTAL | Participants will receive JNJ-89853413 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-89853413 at the RP2D determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-89853413 | DRUG | JNJ-89853413 will be administered. |
Inclusion Criteria: * Have a diagnosis, per World Health Organization (WHO) 2022 criteria of: 1. relapsed/refractory acute myeloid leukemia (AML) 2. relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System ...
JNJ-89853413 is an investigational small molecule being studied for the treatment of acute myeloid leukemia and myelodysplastic neoplasms. It is currently in Phase 1 clinical development for patients with relapsed or refractory disease.
The specific molecular target of JNJ-89853413 has not been disclosed. It is a small molecule being investigated for its potential activity in acute myeloid leukemia and myelodysplastic neoplasms.
JNJ-89853413 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-89853413 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently active but not recruiting participants.
JNJ-89853413 is being evaluated in a Phase 1 clinical trial with the identifier NCT06618001. This study is for patients with relapsed or refractory acute myeloid leukemia or myelodysplastic neoplasms and is being conducted in Canada, Spain, and the United Kingdom.
No alternative names for JNJ-89853413 have been reported. It is identified solely by its investigational code name in clinical trial registries and scientific literature.