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| ID | Type | Description | Link |
|---|---|---|---|
| 78278343PCR1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-005970-83 | EudraCT Number | ||
| 2023-506585-31-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-78278343 | Experimental | Participants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1. Participants who are still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-78278343 | Drug | JNJ-78278343 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 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 1 year and 10 months |
| Part 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 immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. | Up to 1 year and 10 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 1 year and 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-78278343 | Serum concentrations of JNJ-78278343 will be determined. | Up to 1 year and 10 months |
| Systemic Cytokine Concentrations | Cytokine concentrations will be determined for biomarker assessment. |
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Inclusion Criteria:
Exclusion Criteria:
Disease conditions
Prior/Concomitant Therapy
Prior/Concurrent Medical Conditions
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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 |
|---|---|---|---|---|---|---|
| Columbia University Medical Center Herbert Irving Pavilion | New York | New York | 10032 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40450573 | Derived | Stein MN, Vinceneux A, Robbrecht D, Doger B, Autio KA, Schweizer MT, Calvo E, Medina L, Van Dongen M, Deville JL, Bernard-Tessier A, Ghosh D, Shotts K, Shen F, Jaiprasart P, Chaudhary R, Wu S, Cartee L, Schnepp R, Gaut D, Lauring J, Wang SC, Villalobos VM, Baldini C. Pasritamig, a First-in-Class, Bispecific T-Cell Engager Targeting Human Kallikrein 2, in Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. J Clin Oncol. 2025 Aug;43(22):2515-2526. doi: 10.1200/JCO-25-00678. Epub 2025 Jun 1. |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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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| Up to 1 year and 10 months |
| Serum Prostate Specific Antigen (PSA) Concentration | Serum PSA concentration will be measured. | Up to 1 year and 10 months |
| Number of Participants With Anti-JNJ-78278343 Antibodies | Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method. | Up to 1 year and 10 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3). | Up to 1 year and 10 months |
| Radiographic Progression-free Survival (rPFS) | rPFS is defined as time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first. | Up to 1 year and 10 months |
| PSA Response Rate | PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment. | Up to 1 year and 10 months |
| Duration of Response (DOR) | DOR will be calculated among responders (PR or better) 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 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first. | Up to 1 year and 10 months |
| Memorial Sloan Kettering Cancer Center |
| New York |
| New York |
| 10065 |
| United States |
| University of Washington | Seattle | Washington | 98195-9472 | United States |
| Peking University Third Hospital | Beijing | 100191 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | 510710 | China |
| First Affiliated Hospital Of Wenzhou Medical College | Wenzhou | 325399 | China |
| Centre Leon Berard | Lyon | 69373 | France |
| APHM Hopital Timone | Marseille | 13005 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| National Cancer Center Hospital East | Kashiwa | 277 8577 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| Antoni van Leeuwenhoek | Amsterdam | 1066 CX | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp Univ Hm Sanchinarro | Madrid | 28050 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| 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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