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Monoclonal Antibodies
JNJ-78278343 + Cetrelimab 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 10 months
Awards & highlights
Study Summary
This trial is researching the safe dose of two new drugs for cancer treatment.
Who is the study for?
This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has spread. They should have tried at least one other treatment like abiraterone or chemotherapy, be relatively healthy (ECOG status of 0 or 1), and have adequate organ function. Men can't join if they've had recent autoimmune disease treatments, unresolved side effects from previous cancer therapies (except minor nerve damage or hair loss), transplants, serious infections, heart/lung problems, or allergies to the drugs being tested.Check my eligibility
What is being tested?
The study is testing a combination of two drugs: JNJ-78278343 and Cetrelimab in patients with metastatic castration-resistant prostate cancer. The first part will find the best doses to use while checking safety. The second part will see how safe these doses are when more people take them.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since both drugs work by boosting it—this could lead to inflammation in different parts of the body. There might also be typical drug infusion reactions as well as general fatigue and issues affecting organs due to increased immune activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 10 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 Adverse Events (AEs) by Severity
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate (ORR)
Prostate Specific Antigen (PSA) Response Rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)Experimental Treatment2 Interventions
Participants will receive subcutaneous (SC) administration of JNJ-78278343 in combination with intravenous (IV) infusion of cetrelimab during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D). Participants will receive the combination treatment at the RP2D in Part 2 (dose expansion)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetrelimab
2022
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,672 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
3,960,258 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:- My cancer can be measured or seen on tests.I do not have serious infections or major heart, lung, or other health issues.My side effects from previous cancer treatments have mostly gone away.My prostate cancer has spread and does not respond to hormone therapy.My organs are functioning well.I have had treatment for advanced prostate cancer with specific medications or chemotherapy.I am fully active or can carry out light work.I am not allergic to any components of JNJ-78278343 or cetrelimab.I have had a solid organ or bone marrow transplant.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and 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.
Are there multiple health centers participating in this medical experiment within the city limits?
"This trial has 8 potential sites for enrollment, such as Start Midwest in Grand Rapids, Macquarie University in Macquarie University and Peter MacCallum Cancer Centre in Melbourne."
Answered by AI
Is enrollment available for this research endeavor?
"The trial's entry on the clinicaltrials.gov website confirms that this experiment is no longer actively recruiting subjects, as it was first posted on April 27th 2023 and its most recent update occured on April 6th 2023. Nevertheless, there are 1261 other studies in need of participants at the moment."
Answered by AI
What potential risks have been associated with JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)?
"Our team assigned a value of 1 to the safety of JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) due to this study's Phase 1 status; meaning that available evidence is sparse for both efficacy and security."
Answered by AI
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