A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Conditions
Prostatic NeoplasmsDrugs
JNJ-78278343Summary
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 Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
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-78278343Description:
JNJ-78278343 will be administered.
Outcome Measures
Primary Outcome Measures
Part 1 and 2: Number of Participants With Adverse Events (AEs)
Part 1 and 2: Number of Participants With AEs by Severity
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Secondary Outcome Measures
Serum Concentration of JNJ-78278343
Systemic Cytokine Concentrations
Serum Prostate Specific Antigen (PSA) Concentration
Number of Participants With Anti-JNJ-78278343 Antibodies
Objective Response Rate (ORR)
Radiographic Progression-free Survival (rPFS)
PSA Response Rate
Duration of Response (DOR)
Timeline
Last Updated
October 24, 2024Start Date
May 24, 2021Today
February 5, 2025Completion Date ( Estimated )
February 16, 2026
Sponsors of this trial
Lead Sponsor
Janssen Research & Development, LLC