A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Clinicaltrials.gov ID: NCT04898634
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 260

Conditions

Prostatic Neoplasms

Drugs

JNJ-78278343

Summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

Locations

3 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Status

  • RECRUITING

Central Contacts

Study Director

  • Janssen Research & Development, LLC Clinical Trial

Eligibility Criteria

Inclusion Criteria:

* Confirmed adenocarcinoma of the prostate which has spread to other body parts
* Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
* Measurable or evaluable disease
* Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog

Exclusion Criteria:

Disease conditions

* Active central nervous system (CNS) involvement
* Toxicity related to prior anticancer therapy has not adequately recovered

Prior/Concomitant Therapy

* Prior treatment with human kallikrein (KLK) 2-targeted therapy
* Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug
* Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug

Prior/Concurrent Medical Conditions

* Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug
* Solid organ or bone marrow transplantation
* Major clotting diseases within one month prior to the first dose of study drug
* Active autoimmune disease within 12 months prior to the first dose of study drug
* Active infection
* Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug
* Clinically significant lung diseases
* Active or chronic hepatitis B or hepatitis C infection
* Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
* Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

Study Plan

JNJ-78278343

EXPERIMENTAL

Participants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1.

  • DRUG:

    JNJ-78278343

    Description:

    JNJ-78278343 will be administered.

Outcome Measures

Primary Outcome Measures

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

Time Frame: Up to 1 year and 10 months

Part 1 and 2: Number of Participants With AEs by Severity

Time Frame: Up to 1 year and 10 months

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

Time Frame: Up to 1 year and 10 months

Secondary Outcome Measures

Serum Concentration of JNJ-78278343

Time Frame: Up to 1 year and 10 months

Systemic Cytokine Concentrations

Time Frame: Up to 1 year and 10 months

Serum Prostate Specific Antigen (PSA) Concentration

Time Frame: Up to 1 year and 10 months

Number of Participants With Anti-JNJ-78278343 Antibodies

Time Frame: Up to 1 year and 10 months

Objective Response Rate (ORR)

Time Frame: Up to 1 year and 10 months

Radiographic Progression-free Survival (rPFS)

Time Frame: Up to 1 year and 10 months

PSA Response Rate

Time Frame: Up to 1 year and 10 months

Duration of Response (DOR)

Time Frame: Up to 1 year and 10 months

Timeline

  • Last Updated
    October 24, 2024
  • Start Date
    May 24, 2021
  • Today
    January 21, 2025
  • Completion Date ( Estimated )
    February 16, 2026

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