← Back to Search

Monoclonal Antibodies

JNJ-69086420 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

Treatment with other agents for prostate cancer, if received, must have been discontinued greater than or equal to (>=) 2 weeks prior to first dose of study drug.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Part 1: Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, or samarium therapy or radioconjugate therapy

Active or chronic hepatitis B or hepatitis C infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years and 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see what dosage is safe and effective, and if it has any preliminary signs of clinical activity.

Who is the study for?

This trial is for men with advanced prostate cancer who have already tried at least one androgen receptor therapy, like abiraterone or enzalutamide. They should be relatively healthy otherwise, with good organ function and a performance status showing they can handle daily activities well. Men who've had certain radioactive treatments or have blood disorders, active hepatitis, or allergies to the study drug can't join.

What is being tested?

The trial is testing JNJ-69086420, a new medication linked to a radioactive substance that targets prostate cancer cells. The first part of the study finds the best dose to use while checking safety. The second part sees how well it works at that dose and monitors any side effects.

What are the potential side effects?

Potential side effects aren't detailed here but may include typical reactions related to radioconjugate therapies such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies, kidney issues from radiation exposure, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I stopped any prostate cancer treatments at least 2 weeks before starting the study drug.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously received treatment with radium Xofigo, strontium, samarium therapy, or radioconjugate therapy.

Select...

I have an active or chronic hepatitis B or C infection.

Select...

I have a history of blood cancer or conditions that could turn into blood cancer.

Select...

I am not allergic to JNJ-69086420 or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years and 4 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 AEs by Severity

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

Secondary study objectives

Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420

Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420

Number of Participants With Anti-JNJ-69086420 Antibodies

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants in one or more cohorts will receive intravenous (IV) injection of JNJ-69086420 at the RP2D(s) determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will receive intravenous (IV) injection of JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

0 / 6Eligibility criteria met