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| ID | Type | Description | Link |
|---|---|---|---|
| 80038114PCR1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET). |
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| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-80038114 | Drug | JNJ-80038114 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: 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 2 Years 6 Months |
| Parts 1 and 2: 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. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. | Up to 2 Years 6 Months |
| Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) | Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. | Up to 2 Years 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-80038114 | Serum concentration of JNJ-80038114 will be determined. | Up to 2 Years 6 Months |
| Systemic Cytokine Concentrations | Cytokine concentrations will be determined for biomarker assessment. |
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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 |
|---|---|---|---|---|---|---|
| University Of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Sidney Kimmel Cancer Center - Jefferson Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41493473 | Derived | Hudson A, Jayaram A, Garmezy B, Zorko NA, Zarrabi KK, Mathews L, Rupnow B, Li M, Ghosh D, Urtishak K, Francis P, Wang SC, Attiyeh E, de Bono J. A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2026 Jan 6;96(1):5. doi: 10.1007/s00280-025-04846-w. |
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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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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 2 Years 6 Months |
| Serum Prostate Specific Antigen (PSA) Concentration | Serum PSA concentration will be determined. | Up to 2 Years 6 Months |
| Number of Participants With Antibodies to JNJ-80038114 | Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method. | Up to 2 Years 6 Months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have a partial response (PR) or better according to Prostate Cancer Working Group 3 (PCWG3) response criteria. | Up to 2 Years 6 Months |
| PSA Response Rate | PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline. | Up to 2 Years 6 Months |
| Duration of Response (DOR) | DOR is defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 response criteria, or death due to any cause, whichever occurs first. | Up to 2 Years 6 Months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| University College London Hospitals NHSFT | London | NW1 2PG | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |