A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: JNJ-80038114

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHSFT
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust Christie Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center - Jefferson Health
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
• Measurable or evaluable disease
• At least 1 prior treatment for mCRPC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ functions as defined by certain laboratory values
• Must sign an informed consent form (ICF)
• Participants must agree to use a highly effective form of birth control as guided by the study doctor

Exclusion Criteria:

• Concurrent anticancer therapy
• Severe or long-lasting side effects related to prior anticancer therapy
• Known allergies to JNJ-80038114 or its excipients
• Brain metastasis or known seizure history
• Significant infections or lung, heart or other medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Escalation; 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).	Drug: JNJ-80038114; JNJ-80038114 will be administered.
Experimental: Part 2: Dose Expansion; Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.	Drug: JNJ-80038114; JNJ-80038114 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 and 2: Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.	Up to 2 Years 6 Months
Parts 1 and 2: Number of Participants With AEs by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.	Up to 2 Years 6 Months
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)	Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.	Up to 2 Years 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentration of JNJ-80038114	Serum concentration of JNJ-80038114 will be determined.	Up to 2 Years 6 Months
Systemic Cytokine Concentrations	Cytokine concentrations will be determined for biomarker assessment.	Up to 2 Years 6 Months
Serum Prostate Specific Antigen (PSA) Concentration	Serum PSA concentration will be determined.	Up to 2 Years 6 Months
Number of Participants With Antibodies to JNJ-80038114	Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.	Up to 2 Years 6 Months
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who have a partial response (PR) or better according to Prostate Cancer Working Group 3 (PCWG3) response criteria.	Up to 2 Years 6 Months
PSA Response Rate	PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.	Up to 2 Years 6 Months
Duration of Response (DOR)	DOR is defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 response criteria, or death due to any cause, whichever occurs first.	Up to 2 Years 6 Months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CR109209; 80038114PCR1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No