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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years 7 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of Response (DOR)

Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

Objective Response Rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 3Eligibility criteria met