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| ID | Type | Description | Link |
|---|---|---|---|
| 75229414MPC1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine recommended Phase 2 dose (RP2D) regimen(s) of JNJ-75229414 in Part 1 (Dose Escalation and to determine safety at the RP2D regimen(s) in Part 2 (Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive a conditioning regimen of cyclophosphamide and fludarabine intravenously (IV) followed by JNJ-75229414 IV infusion escalated sequentially with a targeted dose consistent with the dose required by the cohort being enrolled to determine recommended Phase 2 dose (RP2D) regimen(s). Additional, intermediate dose levels may be implemented based on the review of all available data including, but not limited to, safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) by the study evaluation team (SET). Participants may receive bridging therapy (anti-androgen receptor agents [example, abiraterone, enzalutamide] and radiotherapy, or chemotherapy [example, docetaxel]) if clinically indicated to maintain disease stability. |
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| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-75229414 | Drug | JNJ-75229414 infusion will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. | Up to 15 years 9 months |
| Number of Participants with AEs by Severity | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. | Up to 15 years 9 months |
| Part 1: Number of Participants with Dose-limiting Toxicity (DLT) | 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. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414 | Cmax is the maximum observed plasma concentration of JNJ-75229414. | Up to 15 years 9 months |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75229414 |
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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 |
|---|---|---|---|---|---|---|
| City of Hope Cancer Center | Duarte | California | 91010 | United States | ||
| Norton Cancer Institute |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Bridging Therapy | Drug | Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously. |
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Tmax is the actual sampling time to reach maximum observed plasma concentration of JNJ-75229414.
| Up to 15 years 9 months |
| Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414 | AUC(0-t) is the area under the plasma concentration versus time curve from time zero to 't' time. | Up to 15 years 9 months |
| Peripheral T Cell Expansion and Persistence via Monitoring Chimeric Antigen Receptor T (CAR-T) Positive Cell Counts | Peripheral T cell expansion and persistence via monitoring CAR-T positive cell counts will be reported. | Up to 15 years 9 months |
| Number of Participants With Presence of Anti-JNJ-75229414 Antibodies | Number of participants with antibodies to JNJ-75229414 will be reported. | Up to 15 years 9 months |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve a confirmed best overall response of Complete Response (CR) or Partial Response (PR) evaluated by an independent local radiology review based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Prostate Cancer Working Group 3 (PCWG3) criteria will be used to assess progressive bone metastases. | Up to 15 years 9 months |
| Disease Control Rate (DCR) | DCR is defined as the sum of CR, PR, and stable disease (SD). | Up to 15 years 9 months |
| Duration of Response (DoR) | DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first. | Up to 15 years 9 months |
| Time to response (TTR) | TTR defined as the time from the date of first dose of study drug to the date of first documented response. | Up to 15 years 9 months |
| Peripheral Blood Quantitation of Vesicular Stomatitis Virus G glycoprotein (VSV-G) Copy Numbers | Peripheral blood quantitation of VSV-G copy numbers will be reported. | Up to 15 years 9 months |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| 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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