Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04898634
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04898634
Study Brief:
Protocol Section:
NCT04898634