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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years and 4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
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 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 outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,199 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
745 Previous Clinical Trials
3,959,796 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received treatment with radium Xofigo, strontium, samarium therapy, or radioconjugate therapy.I stopped any prostate cancer treatments at least 2 weeks before starting the study drug.My prostate cancer is advanced, resistant to hormone therapy, and confirmed as adenocarcinoma.I am fully active or can carry out light work.I have an active or chronic hepatitis B or C infection.Side effects from my previous cancer treatments are mild or gone, except for hair loss, scar tissue from radiation, or nerve pain.I have a history of blood cancer or conditions that could turn into blood cancer.I am not allergic to JNJ-69086420 or its ingredients.My organ functions are within normal ranges according to recent tests.I have been treated with a specific prostate cancer medication before.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned JNJ-69086420 for public use?
"Given that this is a Phase 1 trial and there are only minimal data points supporting JNJ-69086420's safety and efficacy, our team has assigned it a score of 1 on the scale."
Answered by AI
What salient objectives is this clinical trial hoping to fulfill?
"According to Janssen Research & Development, LLC., the main metric assessed over a 2 year and 4 month period is adverse events as an indication of safety and tolerability. Additionally, secondary objectives like overall response rate (ORR) according to RECIST 1.1 without evidence of bone progression in PCWG3 will be monitored. Other metrics include maximum observed serum concentration/radioactivity of JNJ-69086420 (Cmax), and time taken to reach this peak level (Tmax)."
Answered by AI
Are there any vacancies for individuals to join this research endeavor?
"The information hosted on clinicaltrials.gov supports the assertion that this trial is currently enrolling patients. This research project was originally published on November 12th 2020, and has been recently revised as of November 22nd 2022."
Answered by AI
In what regions is this investigation being conducted?
"At present, there are 7 centres enrolled in this trial. Individuals can choose from sites located in New york, Duarte and Los Angeles as well as 4 other cities to minimize their travel burden when participating."
Answered by AI
What aggregate figure of participants is involved with this trial?
"Confirmed, the clinical trial is still actively recruiting. Initially posted on November 12th 2020, this study requires 70 participants from 7 different medical locations to move forward."
Answered by AI
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