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Completed

NCT Number: NCT05441501

A Study of JNJ-80038114 in Participants With 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).

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University College London Hospitals NHSFT, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-80038114

Drug

JNJ-80038114 will be administered.

Primary outcomes

  1. Parts 1 and 2: Number of Participants With Adverse Events (AEs)

    Time frame: Up to 2 Years 6 Months

    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.

  2. Parts 1 and 2: Number of Participants With AEs by Severity

    Time frame: Up to 2 Years 6 Months

    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.

  3. Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

    Time frame: Up to 2 Years 6 Months

    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.

Secondary outcomes

  1. Serum Concentration of JNJ-80038114

    Time frame: Up to 2 Years 6 Months

    Serum concentration of JNJ-80038114 will be determined.

  2. Systemic Cytokine Concentrations

    Time frame: Up to 2 Years 6 Months

    Cytokine concentrations will be determined for biomarker assessment.

  3. Serum Prostate Specific Antigen (PSA) Concentration

    Time frame: Up to 2 Years 6 Months

    Serum PSA concentration will be determined.

  4. Number of Participants With Antibodies to JNJ-80038114

    Time frame: Up to 2 Years 6 Months

    Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.

  5. Objective Response Rate (ORR)

    Time frame: Up to 2 Years 6 Months

    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.

  6. PSA Response Rate

    Time frame: Up to 2 Years 6 Months

    PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.

  7. Duration of Response (DOR)

    Time frame: Up to 2 Years 6 Months

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2022
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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