NL-OMON53995招募中不适用
A Phase 1 Study of JNJ-78278343, a T Cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer - 78278343PCR1001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Each potential participant must satisfy all of the following criteria to be
- •enrolled in the study:
- •1. 18 years of age or older.
- •Disease Characteristics
- •2. Confirmed adenocarcinoma of the prostate which has spread to other body
- •3. Measurable or evaluable disease
- •4. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted
- •therapy or chemotherapy.
- •5. 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.
- •6. Concurrent use of any other anticancer treatment.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Any potential participant who meets any of the following criteria will be
- •excluded from participating in the study:
- •Disease Conditions
- •1. Active central nervous system (CNS) involvement.
- •2. Toxicity related to prior anticancer therapy has not adequately recovered.
- •Prior/Concomitant Therapy
- •3. Prior treatment with KLK2-targeted therapy.
- •4. Received, or are receiving, medications that suppress the immune system
- •within 3 days prior to the first dose of study drug.
- •5. Received or plans to receive any live, attenuated vaccine within 4 weeks
- •prior to the first dose of study drug.
- •Prior/Concurrent Medical Conditions
- •6. Diagnosis of cancer other than prostate cancer within 2 years prior to the
- •first dose of study drug.
- •7. Solid organ or bone marrow transplantation.
- •8. Major clotting diseases within one month prior to the first dose of study
- •9. Active autoimmune disease within 12 months prior to the first dose of study
- •10. Active infection.
- •11. Major diseases of heart and blood vessels within 6 months prior to the
- •first dose of study drug.
- •12. Clinically significant lung diseases.
- •13. Active or chronic hepatitis B or hepatitis C infection.
- •14. Known positive test result for human immunodeficiency virus (unless stable
- •on antiretroviral therapy with undetectable viral load).
- •16. Any serious underlying medical conditions or other issue that would impair
- •the ability of the participant to receive or tolerate the planned treatment.
研究者
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