A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-78278343, JNJ-87189401, Apalutamide, Lutetium Lu-177 Vipivotide Tetraxetan.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasms. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, France, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug JNJ-78278343
JNJ-78278343 will be administered. - Drug JNJ-87189401
JNJ-87189401 will be administered. - Drug Apalutamide
Apalutamide will be administered. - Drug Lutetium Lu-177 Vipivotide Tetraxetan
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. - Drug JNJ-101556143
JNJ-101556143 will be administered.
Primary outcome measures
- Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) [Time frame: Up to 21 days after first combination dose of study drugs]
- Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 4 years 8 months]
Secondary outcome measures (7)
- Serum Concentrations of JNJ-87189401 and JNJ-78278343 [Time frame: Up to 4 years 8 months]
- Plasma Concentration of JNJ-101556143 [Time frame: Up to 4 years 8 months]
- Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 [Time frame: Up to 4 years 8 months]
- Objective Response Rate (ORR) [Time frame: Up to 4 years 8 months]
- Radiographic Progression-Free Survival (rPFS) [Time frame: Up to 4 years 8 months]
- Prostate Specific Antigen (PSA) Response Rate [Time frame: Up to 4 years 8 months]
- Duration of Response (DOR) [Time frame: Up to 4 years 8 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- University of Colorado Anschutz Medical Campus — Aurora
- Emory University Winship Cancer Institute — Atlanta
- University Of Minnesota — Minneapolis
- START New Jersey — East Brunswick
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York
- Oregon Health And Science University — Portland
- Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia
- Tennessee Oncology — Nashville
- … and 3 more centers
France · 3 centers
- Institut Bergonie — Bordeaux
- Centre Leon Berard — Lyon
- Institut Gustave Roussy — Villejuif
Australia · 2 centers
- Greenslopes Private Hospital — Greenslopes
- Peter MacCallum Cancer Centre — Melbourne
China · 1 center
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
Japan · 1 center
- The Cancer Institute Hospital of JFCR — Tokyo
Identifiers
NCT: NCT06095089 · CR109330 · 87189401PCR1001 · 2023-504063-17-00