Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-67571244 · 1 trial · 2 indications
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 dose-limiting toxicity will be assessed. The DLTs are based on drug-related adverse events and defined as any of the following events: infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or hematologic toxicity.
The DLT evaluation period is defined as the first 28 days after a participant's first infusion (Day 1). Severity criteria is based on Grade 1, 2, 3, 4 and 5, will be assessed by the investigator as per below grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.
ORR is defined as the percentage of participants who have complete response (CR) and incomplete blood count recovery (CRi) (AML) or CR and partial response (PR) (MDS) as per modified International Working Group response (IWGR) criteria.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-67571244. 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. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants in 2 expansion cohorts of acute myeloid leukemia (AML) or either high-risk myelodysplastic syndromes (MDS) or very high-risk MDS will receive JNJ-67571244 at the RP2D determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-67571244 | DRUG | JNJ-67571244 will be administered. |
Inclusion Criteria: * A diagnosis of: a) Acute Myeloid Leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options b) high-risk or very high-risk Myelodysplastic Syndrome (MDS) accor...
JNJ-67571244 is an investigational small molecule being studied for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is intended for participants with relapsed or refractory disease, meaning the cancer has returned or has not responded to prior treatment.
JNJ-67571244 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-67571244 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed, but it remains in early-stage clinical testing.
JNJ-67571244 has been studied in one clinical trial, identified as NCT03915379. This Phase 1 study enrolled 68 participants with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes and was conducted in the United States, Germany, and Spain.
No alternative names for JNJ-67571244 have been disclosed. The drug is identified solely by its development code, JNJ-67571244, in clinical trial records.