Clinical trial NCT05441501: A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Keywords: Prostate cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Parts 1 and 2: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 2 Years 6 Months
measure: Parts 1 and 2: Number of Participants With AEs by Severity
timeFrame: Up to 2 Years 6 Months
measure: Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
timeFrame: Up to 2 Years 6 Months
Secondary outcomes:
measure: Serum Concentration of JNJ-80038114
timeFrame: Up to 2 Years 6 Months
measure: Systemic Cytokine Concentrations
timeFrame: Up to 2 Years 6 Months
measure: Serum Prostate Specific Antigen (PSA) Concentration
timeFrame: Up to 2 Years 6 Months
measure: Number of Participants With Antibodies to JNJ-80038114
timeFrame: Up to 2 Years 6 Months
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 Years 6 Months
measure: PSA Response Rate
timeFrame: Up to 2 Years 6 Months
measure: Duration of Response (DOR)
timeFrame: Up to 2 Years 6 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: London
country: United Kingdom
facility: University College London Hospitals NHSFT
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust Christie Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: