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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441501
• Other study ID #: CR109209
• Secondary ID: 80038114PCR1001
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 31, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• JNJ-80038114
JNJ-80038114 will be administered.

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHSFT	London
United Kingdom	The Christie NHS Foundation Trust Christie Hospital	Manchester
United Kingdom	Royal Marsden Hospital	Sutton
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Sidney Kimmel Cancer Center - Jefferson Health	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Serum Concentration of JNJ-80038114	Serum concentration of JNJ-80038114 will be determined.	Up to 2 Years 6 Months
Secondary	Systemic Cytokine Concentrations	Cytokine concentrations will be determined for biomarker assessment.	Up to 2 Years 6 Months
Secondary	Serum Prostate Specific Antigen (PSA) Concentration	Serum PSA concentration will be determined.	Up to 2 Years 6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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