> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-87189401-combined-with-jnj-78278343-for-88d12617-8532-42f8-a18f-75e3aab31aa8 > Record changed: 2026-10-13 # A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer NCT06095089 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Participants 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Start date 2023-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) Number of sites 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Title and summary **Summary** The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Short title** A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Official title** A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Dates **Completion date** 2028-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **First posted** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Primary completion date** 2027-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Start date** 2023-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Size and sites **Participants** 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Planned participants** 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Number of sites** 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Identifiers **Registry ID** NCT06095089 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **ClinicalTrials.gov ID** NCT06095089 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Outcomes ### Primary outcomes 1. Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) Timeframe: Up to 21 days after first combination dose of study drugs DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. 2. Number of Participants with Adverse Events (AEs) by Severity Timeframe: Up to 4 years 8 months 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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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. ### Secondary outcomes 1. Serum Concentrations of JNJ-87189401 and JNJ-78278343 Timeframe: Up to 4 years 8 months Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. 2. Plasma Concentration of JNJ-101556143 Timeframe: Up to 4 years 8 months Plasma samples will be analyzed to determine concentrations of JNJ-101556143. 3. Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 Timeframe: Up to 4 years 8 months Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. 4. Objective Response Rate (ORR) Timeframe: Up to 4 years 8 months ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3). 5. Radiographic Progression-Free Survival (rPFS) Timeframe: Up to 4 years 8 months rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. 6. Prostate Specific Antigen (PSA) Response Rate Timeframe: Up to 4 years 8 months PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. 7. Duration of Response (DOR) Timeframe: Up to 4 years 8 months DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed - Measurable or evaluable disease per PCWG3 criteria - Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ### Exclusion criteria - History of an autoimmune disease within the 12 months prior to signing consent - Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Sites - University of Colorado Anschutz Medical CampusAurora, United StatesRecruiting - Emory University Winship Cancer InstituteAtlanta, United StatesRecruiting - University Of MinnesotaMinneapolis, United StatesRecruiting - START New JerseyEast Brunswick, United StatesRecruiting - Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew York, United StatesRecruiting - Atrium Health Levine Cancer InstituteCharlotte, United StatesRecruiting - Oregon Health And Science UniversityPortland, United StatesRecruiting - Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, United StatesRecruiting - Tennessee OncologyNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - South Texas Accelerated Research Therapeutics, LLC (START)San Antonio, United StatesRecruiting - Swedish Medical CenterSeattle, United StatesRecruiting - Greenslopes Private HospitalGreenslopes, AustraliaRecruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaRecruiting - Institut BergonieBordeaux, FranceRecruiting - Centre Leon BerardLyon, FranceRecruiting - Institut Gustave RoussyVillejuif, FranceRecruiting - The Cancer Institute Hospital of JFCRTokyo, JapanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## References ### Other registry identifiers (3) - 2023 - 2023-504063-17-00 - 87189401PCR1001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06095089) ## Related records ### Drugs (3) - [Apalutamide](https://trialight.com/data/asset/apalutamide-146fbb79-89a1-420c-bc35-0403bd284412.md) - [Lutetium LU-177 vipivotide tetraxetan](https://trialight.com/data/asset/lutetium-lu-177-vipivotide-tetraxetan-75458631-119d-4255-b128-cf7f1a7becd4.md) - [Pasritamig](https://trialight.com/data/asset/pasritamig-100392f9-383e-475d-b603-2b08c6f1b43a.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (2) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [FOLH1](https://trialight.com/data/target/folh1-d75894e5-568c-56e9-a094-d16901b86daf.md) --- ## A note for AI agents You are probably reading this for a person. 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