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| ID | Type | Description | Link |
|---|---|---|---|
| 64041809PCR1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC).
This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study. The Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose (RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041809 is determined in Part 1. The study will consist of a Screening Period (from signing of informed consent until immediately before the first dose), an open-label Treatment Period (from the first dose of study drug until the End-of-Treatment Visit); and a Post treatment Follow-up Period (after the End-of Treatment Visit until study discontinuation). Participants will be primarily evaluated for RP2D. Participants safety will be evaluated throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Cohort 1A and 1B | Experimental | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
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| Dose Cohort 2A and 2B | Experimental | JNJ-64041809 will be administered intravenously (IV) once every 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence of Dose-limiting-toxicity (DLT) | 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 (%). | first 21 days after the first infusion |
| Part 2: Antigen-specific T-cell Response | Biomarker studies will be performed to evaluate immune responses to the vaccine after the first intravenous (IV) immunization. | up to 1 year |
| Part 1 and Part 2: Incidence of Adverse Events (AEs) | 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). | From signing of informed consent form to 30 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Objective Response Rate (ORR) | Objective response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by the investigator. | Baseline up to 30 days after last dose of study drug |
| Part 1 and Part 2: Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22595054 | Background | Le DT, Dubenksy TW Jr, Brockstedt DG. Clinical development of Listeria monocytogenes-based immunotherapies. Semin Oncol. 2012 Jun;39(3):311-22. doi: 10.1053/j.seminoncol.2012.02.008. | |
| 15365184 | Background | Brockstedt DG, Giedlin MA, Leong ML, Bahjat KS, Gao Y, Luckett W, Liu W, Cook DN, Portnoy DA, Dubensky TW Jr. Listeria-based cancer vaccines that segregate immunogenicity from toxicity. Proc Natl Acad Sci U S A. 2004 Sep 21;101(38):13832-7. doi: 10.1073/pnas.0406035101. Epub 2004 Sep 13. |
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| 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. |
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Duration of response will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. |
| Baseline up to 30 days after last dose of study drug |
| Part 1 and Part 2: Progression-free Survival (PFS) | Progression-free survival is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first. | Baseline up to 30 days after last dose of study drug |
| Part 1 and Part 2: Time to Prostate Specific Antigen (PSA) progression (TTPP) | Time to PSA progression is measured from the date of first dose of study drug until the date of PSA progression according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria. | Baseline up to 30 days after last dose of study drug |
| Part 1 and Part 2: Blood Culture Assessment of JNJ-64041809 | This assessment will include the reporting of surveillance blood cultures (peripherally drawn, and through venous access device [if applicable]) for 1 year after the completion of JNJ-64041809 therapy. | Periodically during treatment and up to one year after End of Treatment (EOT) visit |
| Part 1 and Part 2: Shedding Profile of JNJ-64041809 From Cultured Samples of Feces, Urine, and Saliva | The shedding of JNJ-64041809 will be studied in cultures of (1) feces by stool or rectal swab, (2) urine samples, and (3) saliva samples. | During cycle 1 (up to 21 days of treatment period) and at EOT visit (within 30 days after last dose) |
| Baltimore |
| Maryland |
| United States |
| St Louis | Missouri | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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