NCT06344715Unknown1 期
A Phase 1, Multi-center, Open-label, Dose-escalating Study to Evaluate the Safety and Tolerability of Triple Combination Regimen of SL-T10, GX-I7 and Pembrolizumab in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)
SL VAXiGEN2 个研究点 分布在 2 个国家目标入组 78 人开始时间: 2022年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).
详细描述
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SL-T10, GX-I7, and pembrolizumab in combination in patients with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 19 years of age or older at the date of written informed consent.
- •Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, documented by bone or soft tissue lesions.
- •Patients with castration-resistant prostate cancer with a blood testosterone level of less than 50 ng/dL at the screening visit.
- •patients with metastatic castration-resistant prostate cancer (mCRPC) who meet the following criteria (based on PCWG3.0 modified RECIST 1.1)
- •1) Prior taxane therapy for metastatic prostate cancer or confirmed refusal or inadequacy of such therapy 2) Patients who have received prior docetaxel and at least one of the following agents: abiraterone acetate or enzalutamide before or after docetaxel treatment 3) Patients with progression of prostate cancer during/after prior therapy, in the investigator's judgment, with either of the following, in the internal or external castration state
- •PSA progression defined as at least 2 PSA level increases (≥1 week interval between each test) and a PSA level of ≥2 ng/mL at Screening
- •Advanced soft tissue disease as defined by RECIST 1.1
- •Progressive bone disease defined as ≥2 new lesions on bone scan (per PCWG3)
- •5. Patients who are on androgen deprivation therapy (ADT) of any kind (patients who have not undergone bilateral orchiectomy must begin internal castration therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or anti-androgenic agents, at least 4 weeks prior to Baseline and must continue for the entire duration of the study)
排除标准
- •patient has an active autoimmune disease or is receiving systemic steroid therapy or in immunosuppressive status.
- •Patient has history of chemotherapy, radiation chemotherapy, biological therapy, immunotherapy, or radiation therapy within 4 weeks prior to the screening visit (In case of nitrosoureas or mitomycin, 6 weeks prior to the screening visit)
结局指标
主要结局
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
时间窗: Baseline to 48 weeks
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Baseline to 23 weeks
Number of participants with treatment-emergent adverse events (TEAEs)
次要结局
- PSA progression free survival(Baseline to 48 weeks)
- Radiographic progression free survival(Baseline to 48 weeks)
- PSA response rate(Baseline to 48 weeks)
- Change of induced T-cell responses for SL-T10 vaccine(Baseline to 48 weeks)
研究者
研究点 (2)
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