RecruitingRecruiting
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
NCT06095089 · Janssen Research & Development, LLC
In plain English
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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
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 355 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-01
Estimated completion: 2028-06-28
Last updated: 2026-06-05
Interventions
Drug: JNJ-78278343Drug: JNJ-87189401Drug: ApalutamideDrug: Lutetium Lu-177 Vipivotide TetraxetanDrug: JNJ-101556143
Primary outcomes
- • Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) (Up to 21 days after first combination dose of study drugs)
- • Number of Participants with Adverse Events (AEs) by Severity (Up to 4 years 8 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (15)
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Emory University Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
University Of MinnesotaRecruiting
Minneapolis, Minnesota, United States
START New JerseyRecruiting
East Brunswick, New Jersey, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterRecruiting
New York, New York, United States
Oregon Health And Science UniversityRecruiting
Portland, Oregon, United States
Sidney Kimmel Cancer Center - Jefferson HealthRecruiting
Philadelphia, Pennsylvania, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC (START)Recruiting
San Antonio, Texas, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Institut BergonieRecruiting
Bordeaux, France
Centre Leon BerardRecruiting
Lyon, France
Institut Gustave RoussyRecruiting
Villejuif, France
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan