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JNJ Combo for Prostate Cancer

Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years 7 months
Awards & highlights

Study Summary

This trial tests a combination of drugs to treat advanced prostate cancer, assessing safety and the recommended dose.

Who is the study for?
This trial is for men with advanced prostate cancer who are still able to carry out daily activities (ECOG status of 0 or 1). They must have a specific type of cancer that has spread and is resistant to hormone therapy, with a PSA level over 2 ng/mL. Participants should either have had surgery to remove their testicles or be on hormone-blocking medication.Check my eligibility
What is being tested?
The study tests combining two drugs, JNJ-87189401 and JNJ-78278343, in men with advanced prostate cancer. The first part determines the best doses for safety and effectiveness, while the second part further examines safety at these doses.See study design
What are the potential side effects?
Specific side effects aren't listed here but typically include reactions at the drug injection site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, hormonal imbalances, and potential impacts on liver and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My PSA level is 2 ng/mL or higher and my disease can be measured.
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I have undergone orchiectomy or am on hormone therapy for prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Objective Response Rate (ORR)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)Experimental Treatment2 Interventions
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 (dose expansion).

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,959 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,537 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer
~73 spots leftby Jun 2027
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