Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64041809 · 1 trial · 1 indication
Percentage of Participants who Experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (\>=) 33 percent (%).
Biomarker studies will be performed to evaluate immune responses to the vaccine after the first intravenous (IV) immunization.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
| Arm | Type | Description |
|---|---|---|
| Dose Cohort 1A and 1B | EXPERIMENTAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
| Dose Cohort 2A and 2B | EXPERIMENTAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-64041809 (Cohort 1A and 1B) | BIOLOGICAL | JNJ-64041809 will be administered IV at a lower dose in Cohort 1A (1x10\^8 colony forming units \[CFU\]) and at a higher dose in Cohort 1B (1x10\^9 CFU). |
| JNJ-64041809 (Cohort 2A and 2B) | BIOLOGICAL | JNJ-64041809 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B. |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate with progressive metastatic disease which, in the opinion of the investigator, requires initiation of new treatment. The assessment of disease progression can be based on either PSA rise, new or progressive soft tissue di...
JNJ-64041809 is an investigational immunotherapy that Johnson & Johnson developed for metastatic castration-resistant prostate cancer. It is described as a live attenuated double-deleted Listeria-based immunotherapy, given to male participants aged 18 years and older. It was studied in a single Phase 1 trial that has been completed.
JNJ-64041809 was studied for the treatment of prostatic neoplasms that are castration-resistant, specifically metastatic castration-resistant prostate cancer. The Phase 1 trial enrolled 26 male participants aged 18 years and older in the United States. It is an investigational agent and is not an approved therapy for this indication.
Johnson & Johnson, which trades under the ticker JNJ, developed JNJ-64041809. The company sponsored the Phase 1 study of the agent in metastatic castration-resistant prostate cancer. Johnson & Johnson is the developer associated with this asset.
JNJ-64041809 is in Phase 1 development. Its only registered trial, NCT02625857, was a Phase 1 study that has been completed. The trial enrolled 26 participants and was not randomized and not double blinded, though it did use a controlled design. The drug remains investigational.
JNJ-64041809 was evaluated in one clinical trial, NCT02625857, titled a study of the safety and immunogenicity of JNJ-64041809, a live attenuated double-deleted Listeria immunotherapy, in participants with metastatic castration-resistant prostate cancer. That Phase 1 trial is completed, enrolled 26 participants in the United States, and included only male participants aged 18 years and older.