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JNJ-74856665 · 1 trial · 3 indications
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of participants with AEs by severity will be reported as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-74856665 | EXPERIMENTAL | Participants will receive JNJ-74856665 orally in a 21-day cycle. The dose levels will be escalated based on the decisions of the Study Evaluation Team (SET) until a recommended Phase 2 dose (RP2D) has been identified. |
| Arm B: JNJ-74856665 + Azacitidine (AZA) | EXPERIMENTAL | Participants will receive JNJ-74856665 orally in combination with AZA administered intravenously (IV) or subcutaneously (SC) in a 28-day cycle. |
| Arm C: JNJ-74856665 + Venetoclax (VEN) | EXPERIMENTAL | Participants will receive JNJ-74856665 orally in combination with VEN in a 28-day cycle. |
| Arm D: JNJ-74856665 | EXPERIMENTAL | Participants will receive JNJ-74856665 orally in a 21-day cycle. Participants with transfusion dependent relapsed/refractory Myelodysplastic Syndrome (MDS) will be included. |
| Name | Type | Description |
|---|---|---|
| JNJ-74856665 | DRUG | JNJ-74856665 will be administered orally. |
| AZA | DRUG | AZA will be administered IV infusion or SC injection. |
| VEN | DRUG | VEN tablet will be administered orally. |
Inclusion Criteria: * A diagnosis of: Arms A and C: Acute Myeloid Leukemia (AML) according to the World Health Organization (WHO) 2016 criteria with relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options; or newly transformed secondary AML according to ...
JNJ-74856665 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is also being evaluated in patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML), as part of a Phase 1 clinical trial.
JNJ-74856665 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-74856665 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
JNJ-74856665 has been studied in a Phase 1 clinical trial with the identifier NCT04609826. This trial enrolled 153 participants with Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, and was conducted in France, South Korea, Spain, and the United Kingdom.
No alternative names for JNJ-74856665 have been disclosed. It is identified solely by its investigational code name in clinical trial records.