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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 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

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,582 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

746 Previous Clinical Trials

3,960,168 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the quota for participants in this experiment?

"Affirmative. Clinicaltrials.gov confirms that this investigation, initially uploaded on November 1st 2023, is currently recruiting for subjects. 110 individuals are needed from 5 different clinical hubs."

Answered by AI

Is there any risk associated with the initial and extended components of this protocol?

"Our internal assessment gave Part 1 and 2 of this Phase 1 trial a score of 1, signifying that the safety profile is still largely undetermined."

Answered by AI

Is this medical experiment admitting new participants?

"According to clinicaltrials.gov, this experiment is presently seeking volunteers; the initial posting was on November 1st 2023 and it has been revised since then lastly on November 7th 2023."

Answered by AI

At which locations can participants join this trial?

"Currently, the study is enrolling patients from 5 key medical centres, such as Centre Leon Bérard in Lyon, Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center (New york), and South Texas Accelerated Research Therapeutics LLC (START) in San Antonio."

Answered by AI

What objectives is this clinical experiment attempting to realize?

"This clinical trial is measuring the number of participants who experience adverse events as its primary outcome over a 21-day period. Secondary outcomes monitored include prostate specific antigen response rate, objective response rate, and number of participants with antibodies to JNJ-87189401 and JNJ-78278343."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

2023. "A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095089.

All > Prostate Cancer Austin > Advanced Prostate Cancer