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

Study Identifier:
78278343PCR1001
CT.gov Identifier:
NCT04898634
EudraCT Identifier:
2020-005970-83
EU Trial (CTIS) Number:
2023-506585-31-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Male
    Age
    18 - 64 Years
    Study Drug
  • Drug: Experimental: JNJ-78278343 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. Participants who are still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate