KCT0006160招募中未知
A phase 1/2 clinical trial to evaluate the safety, tolerability, dosimetry and anti-tumor activity of Ga-68-NGUL/Lu-177-DGUL in patients with metastatic castration-resistant prostate cancer (mCRPC) refractory to standard therapy
Cellbion0 个研究点目标入组 73 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 100(Year)（—）
- 性别
- Male
入选标准
- •* Healthy Participants
- •1) Male over 19 years old
- •2) Participants do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
- •3) Participants will be determined to be suitable as subjects as a result of clinical pathology tests such as blood pathology tests, blood chemistry tests, and urinalysis performed at the screening visit
- •4) Patients who voluntarily agreed to participate in this clinical trial and signed consent form
- •* Prostate cancer patients
- •1) Male patients over 19 years of age
- •2) Patients must have adenocarcinoma confirmed by histopathology or cytology.
- •3) Blood testosterone level meets the castration criterion (<50 ng/dL).
- •4) Patients with advanced metastatic castration-resistant prostate cancer who have failed the standard of care, and satisfy the following criteria:
- •-Previous treatment history for mCRPC: Patients who administered at least one of enzalutamide or abiraterone before/after docetaxel treatment.
- •-Patients who have confirmed disease progression before screening according to the Prostate Cancer Clinical Trials Working Group (PCWG) 3 standard in the state of internal/surgical castration during/after the previous treatment.
- •i.Soft-tissue disease progression: Soft tissue disease progression as defined by Solid Cancer Response Assessment Criteria Version 1.1 (RECIST v1.1).
- •ii. Bone disease progression: 2 or more new bone lesions
- •5) Patients must maintain androgenic deprivation therapy (ADT).
- •6) Patients must receive bone resorption treatment.
- •8) ECOG performance status = 2 patients
- •9) Patients must have an expected survival period of 6 months or longer
- •10) Patients must have adequate organ function :
- •-Absolute neutrophil count (ANC) = 1,500/µL (without G-CSF administration within 2 weeks prior to baseline)
- •-Platelet = 100,000/µL (without blood transfusion within 2 weeks prior to baseline)
- •-Hemoglobin = 9.0 g/dL (without blood transfusion within 4 weeks prior to baseline)
- •-Serum creatinine = 1.8 mg/dL or eGFR (or GFR) = 40 mL/min/1.73 m2
- •-Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 X ULN (however, AST and ALT = 5 X ULN in patients with confirmed liver metastasis)
- •-Total bilirubin = 1.5 X ULN (except for Gilbert syndrome)
- •-Prothrombin time (PT) and activated partial thromboplastin time (aPTT) = 1.5 X ULN
- •11) Patients who voluntarily agreed to participate in this clinical trial and signed consent form
排除标准
- •* Healthy Participants
- •1) Participants with clinically significant acute or unstable disease
- •2) Participants have confirmed the following medical history or surgical history/operation history
- •-Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
- •-Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection within 6 months prior to baseline
- •-Acute coronary syndrome within 6 months prior to baseline (unstable angina or myocardial infarction)
- •-Serious cerebrovascular disease such as stroke within 6 months prior to baseline
- •-General anesthesia within 4 weeks before baseline (2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery) or major surgery requiring breathing aids
- •3) Participants with a history of severe drug hypersensitivity and hypersensitivity to drugs of a similar class to Investigational product.
- •4) Participants with severe claustrophobia that are not controlled by anti-anxiety drugs
- •5) Participants have hypersensitivity to the composition of the investigational product.
- •6) If the partner is a woman of childbearing potential, a person who does not intend to abstain for at least 3 months after the end of the clinical period and clinical investigational drug administration, or does not intend to use an appropriate contraceptive method
- •7) Participants who participated in a clinical trial within 6 months prior to baseline.
- •8) Participants are unable to participate in clinical trials when judged by other investigators
- •* Prostate cancer patients
- •1) Patients with hematologic malignancy including solid cancer and lymphoma other than prostate cancer within 3 years of baseline (however, appropriately treated non-melanoma skin cancer and superficial bladder cancer can be registered)
- •2) Patients who received chemotherapy, biotherapy, or immunotherapy for prostate cancer within 4 weeks of baseline (however, 6 weeks before baseline in the case of nitrosoureas or mitomycin)
- •3) Patients who received radiation chemotherapy or radiation therapy within 12 weeks of baseline
- •4) Patients who received high-dose chemotherapy requiring hematopoietic stem cell treatment within 2 years of baseline
- •5) Patients have received any PSMA targeted therapy previously(except DGUL), or who have received radiopharmaceutical treatment such as radium-223 within 6 months of baseline
- •6) Patients with symptomatic central nervous system metastasis
- •7) Patients have confirmed the following medical history or surgical history/operation history
- •-Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
- •-Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection within 6 months prior to baseline
- •-Acute coronary syndrome within 6 months prior to baseline (unstable angina or myocardial infarction)
- •-Serious cerebrovascular disease such as stroke within 6 months prior to baseline
- •-General anesthesia within 4 weeks before baseline (2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery) or major surgery requiring breathing aids
- •8) Patients with the following diseases
- •-Class III or IV heart failure according to the New York Heart Association (NYHA) classification
- •-Uncontrolled hypertension (SBP> 160 mm Hg or DBP> 90 mm Hg)
- •-Clinically significant cardiovascular abnormalities by the investigator
- •-Uncontrolled cardiac arrhythmia
- •-Accompanying known HIV positive test or other uncontrolled
研究者
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