Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-95804306 · 1 trial · 1 indication
DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (\<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
| Arm | Type | Description |
|---|---|---|
| Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS) | EXPERIMENTAL | Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites. |
| Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapy | EXPERIMENTAL | Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL/NHL SoC will not be administered for US sites. |
| Name | Type | Description |
|---|---|---|
| JNJ-95804306 | DRUG | JNJ-95804306 will be administered orally. |
| AML SoC | DRUG | AML SoC will be administered subcutaneously/intravenously. |
| CLL/SLL SoC | DRUG | CLL/SLL SoC will be administered orally/ intravenously. |
Inclusion criteria: For Arm A: * Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international ...
JNJ-95804306 is an investigational small molecule being developed for the treatment of hematologic neoplasms, which are cancers of the blood and bone marrow. It is currently being studied in patients with relapsed or refractory hematological malignancies, meaning cancers that have returned or have not responded to prior treatment.
JNJ-95804306 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this drug candidate for the treatment of hematologic neoplasms.
JNJ-95804306 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with hematologic neoplasms.
JNJ-95804306 is being studied in a Phase 1 clinical trial with the identifier NCT07572006, titled 'A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies.' This trial is currently recruiting participants and aims to enroll 360 patients across multiple countries, including the United States, Australia, Belgium, Denmark, France, Spain, and the United Kingdom.
JNJ-95804306 is the primary identifier for this investigational drug candidate. No alternative names have been reported for this compound in the available clinical trial information. It is being developed by Johnson & Johnson under this specific code name.