A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
NCT ID: NCT06095089
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2023-11-01
2027-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Participants will receive the combination treatment at the RP2R in Part 2 in different disease settings.
JNJ-78278343
JNJ-78278343 will be administered.
JNJ-87189401
JNJ-87189401 will be administered.
Interventions
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JNJ-78278343
JNJ-78278343 will be administered.
JNJ-87189401
JNJ-87189401 will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable or evaluable disease per PCWG3 criteria
* Part 1, Part 2A and Part 2B: 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
* 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Centre Leon Berard
Lyon, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Other Identifiers
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87189401PCR1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504063-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109330
Identifier Type: -
Identifier Source: org_study_id