← Back to Search


JNJ-80038114 for Prostate Cancer

Center for Cancer Research National Cancer Institute, Bethesda, MD
JNJ-80038114Phase 1RecruitingResearch Sponsored by Janssen Research & Development, LLC

Study Summary

This trial is testing a new drug to find the best dose for safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have received treatment before for metastatic castration-resistant prostate cancer.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 6 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: 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 outcome measures
Duration of Response (DOR)
Number of Participants With Antibodies to JNJ-80038114
Objective Response Rate (ORR)
+4 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 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).

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
964 Previous Clinical Trials
6,381,105 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
739 Previous Clinical Trials
3,958,389 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Media Library

JNJ-80038114 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05441501 — Phase 1
Prostate Cancer Research Study Groups: Part 1: Dose Escalation, Part 2: Dose Expansion
Prostate Cancer Clinical Trial 2023: JNJ-80038114 Highlights & Side Effects. Trial Name: NCT05441501 — Phase 1
JNJ-80038114 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441501 — Phase 1
Prostate Cancer Patient Testimony for trial: Trial Name: NCT05441501 — Phase 1

Frequently Asked Questions

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

Are any Canadian healthcare institutions currently testing this therapy?

"Patients for this medical study can be recruited from the Sidney Kimmel Cancer Center - Jefferson Health in Philadelphia, Pennsylvania, University Of Minnesota in Minneapolis, Minnesota and Sarah Cannon Research Institute in Nashville, Tennesseef Minnesota in Minneapolis, Minnesota and Sarah Cannon Research Institute in Nashville, Tennessee as well as 4 other research sites."

Answered by AI

What is the primary aim of this medical investigation?

"The funder of this research trial, Janssen Research & Development, LLC has identified a primary objective to be observed over the course of up to 2 Years and 6 Months: The Number of Participants With AEs by Severity. Additionally, secondary objectives such as Serum Concentration of JNJ-80038114, Prostate Specific Antigen (PSA) Concentration, and Objective Response Rate (ORR), will also be tracked in order to accurately assess outcomes."

Answered by AI

How many participants is this clinical trial recruiting?

"Absolutely. According to the information accessible on clinicaltrials.gov, this medical trial was first posted on November 15th 2022 and is actively seeking participants. The research requires 110 volunteers from 4 different sites in order to continue its progress."

Answered by AI

Does this research endeavor still accept participants at this time?

"Affirmative. The clinical trial, which was first opened on November 15th 2022, is actively recruiting patients as indicated by the data hosted on clinicaltrials.gov. A total of 110 participants must be recruited from 4 separate centres for this study to proceed."

Answered by AI

Has the Food and Drug Administration cleared JNJ-80038114 to be used medicinally?

"As JNJ-80038114 is currently in its initial trials, the safety of this medication is only tentatively established. Thus, it has been assigned a score of 1 out of 3."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University Of Minnesota
Sidney Kimmel Cancer Center - Jefferson Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried a couple other treatments and the past and are looking for better results.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many follow-ups are there?
PatientReceived 1 prior treatment
~48 spots leftby Mar 2025