KCT0008799尚未招募Unknown
A phase 2, multi-center, open-label study to evaluate the safety, tolerability and efficacy of combination regimen of GI-101A and SL-T10 in patients with metastatic castration-resistant prostate cancer (mCRPC)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 72
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male patients aged 19 or older as of the written consent date
- •2. Patients with metastatic diseases documented as bone lesions or soft tissue lesions with adenocarcinoma confirmed by histopathology or cytology
- •3. Patients with castration-resistant prostate cancer with blood testosterone levels below 50 ng/dL during screening visit
- •4. Patients with metastatic geriatric resistant prostate cancer (mCRPC) who meet the following criteria
- •1) Patients with previous Taksen therapy for metastatic prostate cancer or who have been identified as rejection or inadequacy of these treatments
- •2) Aviraterone acetate, enzalutami, regardless of previous docetaxel treatmentde), patients who have taken at least one of the following medications: apalutamide, and darolutamide
- •3) Subjects with progression of prostate cancer during/after previous treatment with internal and external castration as determined by the tester
- •? PSA levels should be =2 ng/mL during PSA progression and screening defined by at least two increases in PSA levels (=1 week interval between each test)
- •? Progressive soft tissue disease as defined by RECIST 1.1
- •? Bone scan shows bone disease progression defined by =2 new lesions (based on PCWG3)
- •5. Regardless of the type, male hormone deprivation therapy, patient maintaining ADT)
- •6. Patients with an expected survival period of 6 months or more as ECOG (Eastern Cooperative oncology group) performance status =2
- •7. A person who has agreed to contraception for at least three months after the clinical trial period and the end of administration of clinical trial drugs, if the partner is a childbearing woman
- •8. A person who has signed and agreed to voluntarily participate in this clinical trial
排除标准
- •1. Patients in immunosuppressed condition (e.g., renal removal, hematopoietic stem cell transplantation, etc.)
- •2. Patients with autoimmune diseases (including but not limited to severe work history, Hashimoto thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, and percutaneous)
- •3. A person whose medical history or surgical history/procedural history is confirmed
- •1) Serious cerebrovascular diseases such as cardiac arrhythmia or pulmonary embolism, acute coronary syndrome (insecure angina or myocardial infarction), stroke, etc. within 6 months prior to the baseline
- •2) Requires general anesthesia or respiratory aids within 4 weeks prior to baseline (but 2 weeks for video thoracoscopic surgery or open-and-closed (ONC) surgery)a major operation that
- •4. Persons with the following diseases
- •1) Cardiac pacemaker use or severe heart failure [Class III or IV heart failure by the New York Heart Association (NYHA) classification], uncontrolled cardiac arrhythmia
- •2) Uncontrolled hypertension (SBP >160 mm Hg or DBP >90 mm Hg)
- •3) Myelodysplastic syndrome (MDS)
- •5. Patients who meet the following criteria in the laboratory performance test
- •1) Absolute neutrophil count (ANC) <1,500/µL (without G-CSF administration within 2 weeks prior to screening)
- •2) Platelet <100,000/µL (without blood transfusion within 2 weeks prior to screening)
- •3) Hemoglobin <9.0 g/dL (without blood transfusion within 2 weeks prior to screening)
- •4) 4) Serum creatinine >1.8 mg/dL eGFR (or GFR) <40 mL/min/1.73 m2
- •5) Aspartate transaminase (AST) and alanine transaminase (ALT) >2.5×ULN (but AST and ALT >5×ULN in patients with confirmed liver metastasis)
- •6) Total bilirubin> 2.0×ULN [Excluding Gilbert syndrome]
- •7) 7) Prothrombin time (PT) activated partial thromboplastin time (aPTT) >1.5×ULN
- •6. Patients receiving Saw palmetto products with PSA antigen reduction effects
- •7. If there is an existing history of active hepatitis B or hepatitis B (defined as HBsAg reactivity) or a known active hepatitis C virus (defined as HCV RNA being identified) infection
- •8. History of chronic liver disease or evidence of cirrhosis (excluding those tested with liver metastasis)
- •9. The history of chemotherapy, radiation chemotherapy, biological therapy, immunotherapy, or radiation therapy within 4 weeks prior to the first administration of the trial drug Patients with (but 6 weeks prior to screening for nitrosoureras or mitomycin)
- •10. A person who has been administered another clinical trial drug within 4 weeks prior to the first administration of a trial drug or has been applied with a clinical trial medical device
- •11. Any of these clinical trial medications expected to overreact to SL-T10 and/or GI-101A
- •12. A person who is deemed unable to use a medical device
- •1) If the Tester determines that the skin condition around the deltoid muscle (2 cm) where the electrical perforator is to be used for infection, ulcer, swelling or tattooing, scarring, trauma, or other reasons is inappropriate for participation in the clinical trial
- •2) Hemophiliac patients at risk of severe uncontrolled bleeding or clotting disorders or ejectiona patient with a tendency to be bloody
- •3) If there is artificial implant due to orthopedic surgery around the deltoid muscle that is to be administered
- •13. A person who has been implanted with an implantable electronic medical device (e.g., a face maker, etc.)
- •14. Patients infected with active HIV or Syphilis
- •15. If you have been di
研究者
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