JNJ-80038114 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sidney Kimmel Cancer Center - Jefferson Health, Philadelphia, PA
Prostate Cancer
JNJ-80038114 - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prostate Cancer

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Up to 2 Years 6 Months

Year 6
Duration of Response (DOR)
Number of Participants With Antibodies to JNJ-80038114
Objective Response Rate (ORR)
PSA Response Rate
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)
Serum Concentration of JNJ-80038114
Serum Prostate Specific Antigen (PSA) Concentration
Systemic Cytokine Concentrations

Trial Safety

Safety Progress

1 of 3

Other trials for Prostate Cancer

Trial Design

2 Treatment Groups

Part 1: Dose Escalation
1 of 2
Part 2: Dose Expansion
1 of 2
Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: JNJ-80038114 · No Placebo Group · Phase 1

Part 1: Dose Escalation
Drug
Experimental Group · 1 Intervention: JNJ-80038114 · Intervention Types: Drug
Part 2: Dose Expansion
Drug
Experimental Group · 1 Intervention: JNJ-80038114 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years 6 months
Closest Location: Sidney Kimmel Cancer Center - Jefferson Health · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Prostate Cancer
0 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,758 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
705 Previous Clinical Trials
3,900,053 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have measurable or evaluable disease.
You have received prior treatment for mCRPC.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.