A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Adva… (NCT04898634) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
United States, China216 participantsStarted 2021-07-13
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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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 dos…
What they're measuring
1
Part 1 and 2: Number of Participants With Adverse Events (AEs)
Timeframe: Up to 1 year and 10 months
2
Part 1 and 2: Number of Participants With AEs by Severity
Timeframe: Up to 1 year and 10 months
3
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)