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JNJ-80038114 for Prostate Cancer
Phase 1
Waitlist Available
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
At least 1 prior treatment for mCRPC
Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
Must not have
Brain metastasis or known seizure history
Known allergies to JNJ-80038114 or its excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find the best amount of a new drug, JNJ-80038114, and ensure it is safe for people who might benefit from it.
Who is the study for?
Men with advanced prostate cancer who have already tried at least one treatment can join this trial. They should be in good physical shape (able to perform daily activities without much help) and have their major organs working well. Participants must agree to use effective birth control, and they cannot have brain metastases, a history of seizures, severe ongoing side effects from previous cancer treatments, or allergies to the study drug.
What is being tested?
The trial is testing JNJ-80038114's safety and optimal dosing for men with advanced prostate cancer. The first part will find the best dose by gradually increasing it among different groups. In the second part, more people will take this found dose to see how safe it is.
What are the potential side effects?
Possible side effects are not detailed here but may include reactions related to prior anticancer therapies since participants with severe lasting effects from such treatments are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment for metastatic castration-resistant prostate cancer.
Select...
My prostate cancer has spread and does not respond to hormone therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My organ functions are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain metastasis or a history of seizures.
Select...
I am allergic to JNJ-80038114 or its ingredients.
Select...
I am not currently receiving any cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Parts 1 and 2: Number of Participants With AEs by Severity
Parts 1 and 2: Number of Participants With Adverse Events (AEs)
Secondary study objectives
Duration of Response (DOR)
Number of Participants With Antibodies to JNJ-80038114
Objective Response Rate (ORR)
+4 moreAwards & 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 will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-80038114
2022
Completed Phase 1
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments primarily target the androgen receptor pathway, which is crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces testosterone levels, slowing cancer progression.
Chemotherapy, such as docetaxel, disrupts cancer cell division. Newer targeted therapies, like enzalutamide and abiraterone, inhibit androgen receptor signaling more precisely.
Understanding these mechanisms helps patients and doctors choose the most effective treatment, manage side effects, and improve outcomes.
Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Androgen deprivation therapy in advanced prostate cancer: is intermittent therapy the new standard of care?Overview of international collaborative group prostate cancer trials.
Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Androgen deprivation therapy in advanced prostate cancer: is intermittent therapy the new standard of care?Overview of international collaborative group prostate cancer trials.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,401,008 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
772 Previous Clinical Trials
3,979,109 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 brain metastasis or a history of seizures.I have had at least one treatment for metastatic castration-resistant prostate cancer.I am allergic to JNJ-80038114 or its ingredients.I do not have serious infections or major heart, lung, or other health issues.My prostate cancer has spread and does not respond to hormone therapy.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be measured or seen on tests.I have severe or long-lasting side effects from previous cancer treatments.I am not currently receiving any cancer treatments.My organ functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Dose Expansion
- Group 2: Part 1: Dose Escalation
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.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT05441501 — Phase 1
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