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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04609826 | A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) | PHASE1 | COMPLETED | 153 | — | — | Nov 26, 2020 | Aug 25, 2025 | Oct 1, 2025 | 20 | France, South Korea +2 |
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 ...