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NCT Number: NCT04898634

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

JNJ-78278343

Drug

JNJ-78278343 will be administered.

Primary outcomes

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

    Time frame: Up to 1 year and 10 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. Part 1 and 2: Number of Participants With AEs by Severity

    Time frame: Up to 1 year and 10 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 immune effector cell associated neurotoxicity syndrome (ICANS) 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 1 year and 10 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-78278343

    Time frame: Up to 1 year and 10 months

    Serum concentrations of JNJ-78278343 will be determined.

  2. Systemic Cytokine Concentrations

    Time frame: Up to 1 year and 10 months

    Cytokine concentrations will be determined for biomarker assessment.

  3. Serum Prostate Specific Antigen (PSA) Concentration

    Time frame: Up to 1 year and 10 months

    Serum PSA concentration will be measured.

  4. Number of Participants With Anti-JNJ-78278343 Antibodies

    Time frame: Up to 1 year and 10 months

    Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.

  5. Objective Response Rate (ORR)

    Time frame: Up to 1 year and 10 months

    ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).

  6. Radiographic Progression-free Survival (rPFS)

    Time frame: Up to 1 year and 10 months

    rPFS is defined as time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.

  7. PSA Response Rate

    Time frame: Up to 1 year and 10 months

    PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment.

  8. Duration of Response (DOR)

    Time frame: Up to 1 year and 10 months

    DOR will be calculated among responders (PR or better) 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 or RECIST version 1.1 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-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 24, 2021
Registry last updated
Jul 6, 2026

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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