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Trial Title:
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
NCT ID:
NCT06095089
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-78278343
Description:
JNJ-78278343 will be administered.
Arm group label:
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Other name:
KLK2-CD3
Intervention type:
Drug
Intervention name:
JNJ-87189401
Description:
JNJ-87189401 will be administered.
Arm group label:
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Other name:
PSMAxCD28
Summary:
The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of
combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further
evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced
prostate cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate
Cancer Working Group 3 (PCWG3): 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; all participants must have a
serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at
time of screening
- 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:
- Active autoimmune disease within the 12 months prior to signing consent that
requires systemic immunosuppressive medications (example, chronic corticosteroids,
methotrexate, or tacrolimus)
- 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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC (START)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Start date:
November 1, 2023
Completion date:
June 21, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095089
