中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126657
最近更新日期： Date of Last Refreshed on：	2026-06-12 17:05:28
注册时间： Date of Registration：	2026-06-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估KMV002在转移性雄激素通路调节耐药前列腺癌（mAPMR）患者中的安全性、耐受性及免疫原性的早期探索性临床研究方案
Public title：	An Early Exploratory Clinical Study Protocol to Evaluate the Safety, Tolerability and Immunogenicity of KMV002 in Patients with Metastatic Androgen Pathway Modulator-Resistant Prostate Cancer (mAPMR)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估KMV002在转移性雄激素通路调节耐药前列腺癌（mAPMR）患者中的安全性、耐受性及免疫原性的早期探索性临床研究方案
Scientific title：	An Early Exploratory Clinical Study Protocol to Evaluate the Safety, Tolerability and Immunogenicity of KMV002 in Patients with Metastatic Androgen Pathway Modulator-Resistant Prostate Cancer (mAPMR)
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	尹皓立	研究负责人：	杨璐
Applicant：	Haoli Yin	Study leader：	Lu Yang
申请注册联系人电话： Applicant telephone：	+86 28 8542 2654	研究负责人电话： Study leader's telephone：	+86 28 8542 2654
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	haoli.yin@chimigen.com	研究负责人电子邮件： Study leader's E-mail：	wycleflue@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	成都天府国际生物城(双流生物城中路二段18号)	研究负责人通讯地址：	四川省成都市武侯区国学巷37号
Applicant address：	Chengdu Tianfu International Bio-city (No. 18, Section 2, Zhonglu, Shuangliu Bio-city)	Study leader's address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	凯米生物医药(成都)有限公司
Applicant's institution：	Kaimi Biopharmaceutical (Chengdu) Co., Ltd.
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital of Sichuan University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2026年审(913)号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	四川大学华西医院生物医学伦理审查委员会
Name of the ethic committee：	Biomedical Ethics Review Committee of West China Hospital, Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-23 00:00:00
伦理委员会联系人：	邓绍林
Contact Name of the ethic committee：	Shaolin Deng
伦理委员会联系地址：	四川省成都市武侯区国学巷37号八角亭2105
Contact Address of the ethic committee：	Room 2105, Baguanting, No. 37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 8542 2654	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

The West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	四川	市(区县)：	成都
Country：	China	Province：	Sichuan	City：	Chengdu
单位(医院)：	四川大学华西医院	具体地址：	四川省成都市武侯区国学巷37号
Institution hospital：	The West China Hospital of Sichuan University	Address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源：

凯米生物医药(成都)有限公司

Source(s) of funding：

Kaimi Biopharmaceutical (Chengdu) Co., Ltd.

研究疾病：

前列腺癌（mAPMR）

Target disease：

Prostate cancer (mAPMR)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

1、主要目的：评估接受不同剂量的KMV002肿瘤治疗性疫苗诱导免疫后的安全性和耐受性，包括不良事件（AE）的发生率、严重程度以及剂量限制性毒性（DLT）。 2、次要目的：评估不同剂量的KMV002诱导的免疫激活效应，特别是PAP特异性免疫应答（抗PAP T细胞反应）。 3、探索性目的：探索KMV002对T细胞增殖、IFN-γ等细胞因子及其他免疫激活标志物的影响；初步观察抗肿瘤活性，包括客观缓解率（ORR）、影像学无进展生存期（rPFS）；评估前列腺特异性抗原（PSA）缓解率（PSA水平较基线下降>=50%的比例）。

Objectives of Study：

1. Main objective: To evaluate the safety and tolerability of KMV002 tumor therapeutic vaccine at different doses, including the incidence, severity of adverse events (AE), and dose-limiting toxicities (DLT). 2. Secondary objective: To assess the immune activation effect induced by different doses of KMV002, particularly the PAP-specific immune response (anti-PAP T cell response). 3. Exploratory objective: To explore the effects of KMV002 on T cell proliferation, cytokines such as IFN-γ, and other immune activation markers; To preliminarily observe the anti-tumor activity, including objective response rate (ORR), radiological progression-free survival (rPFS); To evaluate the prostate-specific antigen (PSA) response rate (the proportion of PSA levels decreasing by >=50% compared to the baseline).

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

经筛选期评估，符合以下所有入选标准的患者方可入组本研究：
1.18岁<=年龄<=80岁的男性；
2.经组织病理学和/或细胞学确诊为前列腺腺癌，允许伴有小细胞或神经内分泌特征的腺癌，但纯小细胞癌、类癌、混合性神经内分泌癌或大细胞神经内分泌癌除外；
3.确诊为APMR（对雄激素通路调节药物产生耐药），即在持续进行雄激素通路抑制治疗（如雄激素剥夺治疗[ADT]、雄激素受体通路抑制剂[ARPI]）期间，仍出现疾病进展，需满足以下所有条件：
既往接受过睾丸切除术或药物去势（在研究治疗首次给药前正在接受促性腺激素释放激素[GnRH]类似物[激动剂或拮抗剂]雄激素剥夺治疗，并且计划在整个治疗期间持续接受该治疗），筛选时血清睾酮水平达到去势水平（＜50 ng/dL或＜1.7 nmol/L）；
疾病进展包括PSA生化进展、影像学进展（PSMA-PET、骨扫描和CT或MRI）：
PSA生化进展：PSA＞1.0 ng/mL且PSA间隔1周，至少连续2次较基础值升高；
软组织/内脏（淋巴结、内脏肺/肝/其他、前列腺/前列腺床）影像学进展：根据RECIST 1.1定义的靶病灶增大或出现新发软组织转移灶；
骨进展：根据PCWG4标准定义的骨进展。
4.既往ARPI使用情况需满足以下条件之一：
既往未使用过第二代ARPI治疗，或
既往接受过第二代无需常规联合糖皮质激素的ARPI且治疗期间仅出现过一次疾病进展，且经研究者评估为适合接受更换为另一种无需常规联合糖皮质激素的ARPI，或
目前正在接受首个第二代无需常规联合糖皮质激素的ARPI（如：恩扎卢胺、阿帕他胺或达罗他胺等，阿比特龙除外）治疗，经研究者评估影像学处于疾病稳定状态，但出现单纯的PSA生化进展；
若既往使用第一代ARPI药物，必须在筛选前停药至少4周（氟他胺）或6周（比卡鲁胺或尼鲁米特）。此外，若患者在停用第一代ARPI后4-6周内出现抗雄激素撤退反应（定义为PSA下降>25%），则需待PSA回升至撤退后最低值以上，方可符合入组条件；
5.无症状或轻微症状，定义为：无需常规使用阿片类镇痛药，且视觉模拟量表疼痛评分≤3分）；
6.存在经影像学确认的转移性病灶，具体表现为：基线期腹部/盆腔CT或MRI检查发现软组织转移灶（需至少满足RECIST 1.1标准下的一个可测量病灶），和/或基线期骨扫描显示存在骨转移。为避免极高肿瘤负荷导致免疫系统过早耗竭，骨转移病灶数量建议控制在适中范围（如≤10个），且不得伴有内脏危象（Visceral Crisis）。仅胸部CT发现转移灶的患者不符合入选标准；
7.血清PSA<=1000 ng/mL； 
8.预期生存>=12个月；
9.体能状态评分（ECOG）为0或1分； 
10.筛选期血液学、肾功能及肝功能指标符合以下要求：
血红蛋白>=9.0 g/dL
中性粒细胞绝对值>=1.0×10^9/L 
血小板计数>=100×10^9/L 
丙氨酸氨基转移酶（ALT）和天冬氨酸转氨酶（AST）<=2.5×ULN（若存在肝转移则需<=4×ULN） 
血清白蛋白>=3.0 g/dL 
血清总胆红素<=1.5×ULN；先天性胆红素血症患者，如吉尔伯特综合征，若结合胆红素<=1.5×ULN则允许入组 
在未使用抗凝治疗的情况下，凝血酶原时间（PT）或国际标准化比率（INR）或活化部分凝血酶原时间（APTT）<=1.5×ULN 
估算或实测肾小球滤过率>=50 mL/min/1.73 m^2 
11.无已知的人类免疫缺陷病毒（HIV）1型和2型、梅毒、活动性乙型肝炎或丙型肝炎病史； 
12.须满足以下与性别相关的避孕/屏障要求： 
已接受双侧睾丸切除术并有记录；或 
同意自筛选期至研究药物末次注射后12个月，禁欲或使用避孕套；且 
同意自筛选期至研究药物末次注射后12个月，不进行精子捐献；且 
男性患者的有生育能力的女性伴侣，除男性使用避孕套外，也应在试验期间（从筛选至研究结束）采取高效避孕措施。 
13.愿意遵守研究要求，并在启动任何研究相关程序前签署书面知情同意书。

Inclusion criteria

After the screening period assessment, patients meeting all the following inclusion criteria can be enrolled in this study:
1. Male patients aged 18 years or above, up to 80 years old;
2. Diagnosed with prostate adenocarcinoma by histopathology and/or cytology, allowing for small cell or neuroendocrine features, but excluding pure small cell carcinoma, carcinoid, mixed neuroendocrine carcinoma or large cell neuroendocrine carcinoma;
3. Diagnosed with APMR (developing resistance to androgen pathway-regulating drugs), that is, during continuous androgen pathway inhibition therapy (such as androgen deprivation therapy [ADT], androgen receptor pathway inhibitors [ARPI]), there is disease progression, and the following conditions must be met:
   - Previously underwent orchiectomy or drug castration (before the first administration of the study treatment, the patient was receiving gonadotropin-releasing hormone [GnRH] analog [agonist or antagonist] androgen deprivation therapy and planned to continue this treatment throughout the treatment period), and the serum testosterone level at the time of screening reached the castration level (< 50 ng/dL or < 1.7 nmol/L);
   - Disease progression includes PSA biochemical progression, imaging progression (PSMA-PET, bone scan and CT or MRI):
     - PSA biochemical progression: PSA > 1.0 ng/mL and PSA increases by at least 1 time interval, at least 2 consecutive times compared to the baseline value;
     - Soft tissue/internal (lymph nodes, internal lungs/liver/other, prostate/prostatic bed) imaging progression: according to RECIST 1.1, the target lesion increases or new soft tissue metastatic lesions appear;
     - Bone progression: according to the PCWG4 criteria, bone progression.
4. The previous use of ARPI must meet one of the following conditions:
   - Previously did not use second-generation ARPI treatment, or
   - Previously received second-generation ARPI without routine combined use of glucocorticoids and only experienced one disease progression during treatment, and was evaluated by the investigator as suitable for switching to another ARPI without routine combined use of glucocorticoids, or
   - Currently receiving the first second-generation ARPI (such as enzalutamide, apalutamide or darolutamide, excluding abiraterone) treatment, and the imaging is in a stable state, but there is only PSA biochemical progression;
   - If previously used first-generation ARPI drugs, the drug must be discontinued for at least 4 weeks (flutamide) or 6 weeks (bicalutamide or nirumiptide). Additionally, if the patient experiences an androgen withdrawal reaction within 4-6 weeks after discontinuation of the first-generation ARPI (defined as a PSA decrease > 25%), the PSA must rise above the lowest value after the withdrawal before meeting the inclusion criteria;
5. No symptoms or mild symptoms, defined as: no need for routine use of opioid analgesics, and visual analog scale pain score ≤ 3 points;
6. There are imaging-confirmed metastatic lesions, specifically manifested as: baseline abdominal/pelvic CT or MRI examination reveals soft tissue metastases (at least one measurable lesion according to RECIST 1.1 criteria), and/or baseline bone scan shows bone metastases. To avoid premature depletion of the immune system due to extremely high tumor burden, the number of bone metastases is recommended to be controlled within an appropriate range (such as ≤ 10), and no visceral crisis (Visceral Crisis) is allowed. Patients with only metastases found on chest CT do not meet the inclusion criteria;
7. Serum PSA ≤ 1000 ng/mL;
8. Expected survival ≥ 12 months;
9. Physical performance score (ECOG) of 0 or 1;
10. Screening period hematological, renal function and liver function indicators meet the following requirements:
   Hemoglobin ≥ 9.0 g/dL
   Absolute neutrophil count ≥ 1.0 × 10^9/L Platelet count >= 100 × 10^9/L
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN (if liver metastasis exists, it should be <= 4 × ULN)
Serum albumin >= 3.0 g/dL
Serum total bilirubin <= 1.5 × ULN; for patients with congenital bilirubinemia, such as Gilbert syndrome, if conjugated bilirubin <= 1.5 × ULN, they are allowed to be enrolled
Without anticoagulation treatment, prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time (APTT) <= 1.5 × ULN
Estimated or measured glomerular filtration rate >= 50 mL/min/1.73 m^2
11. No known history of human immunodeficiency virus (HIV) type 1 and 2, syphilis, active hepatitis B or hepatitis C;
12. Must meet the following gender-related contraception/barrier requirements:
Has undergone bilateral testicular resection and has a record; Or
During the self-screening period until 12 months after the last injection of the study drug, abstinence or the use of a condom is required. And
During the self-screening period until 12 months after the last injection of the study drug, sperm donation will not be conducted. And
For male patients whose female partners are fertile, in addition to the male using condoms, they should also take effective contraceptive measures during the trial period (from screening to the end of the study).
13. Willing to comply with the research requirements and sign a written informed consent form before initiating any research-related procedures.

排除标准：

患者如符合以下任一排除标准，则不得参与本研究： 1.存在已知的脑转移、恶性胸腔积液或恶性腹水； 2.既往抗肿瘤治疗相关毒性未恢复至<=1级或基线水平（脱发、白癜风、2级周围神经病变和放射性组织纤维化除外）； 3.筛选前28天内或研究期间禁止使用以下任何药物：全身性皮质类固醇（剂量不低于相当于每日5 mg泼尼松）——入组前1个月内不允许使用；允许使用吸入、鼻内或局部外用皮质类固醇；阿比特龙或其他必须常规联合全身性糖皮质激素的抗肿瘤药物； PC-SPES 5α还原酶抑制剂——若患者在入组前至少28天已持续使用，可在整个治疗期间继续使用，但研究期间不得新开始使用；己烯雌酚镭-223（Xofigo®）任何其他旨在治疗癌症的激素类药物或补充剂 4.筛选前任何时间曾接受或计划接受针对前列腺酸性磷酸酶的治疗； 5.首次研究用药前4周内曾接种或计划接种任何疫苗（经当地卫生部门授权紧急使用的疫苗，如COVID-19疫苗、狂犬病疫苗、破伤风类毒素疫苗等除外）； 6.筛选前4周内接受过外照射放疗，或研究期间预计需要接受放疗； 7.筛选前3个月内接受过细胞毒性化疗，筛选前任何时间接受过超过2种化疗方案； 8.筛选前4周内因任何原因需要接受阿片类镇痛药治疗； 9.筛选前24周内开始或停用双膦酸盐治疗，正在接受双膦酸盐药物治疗的患者，在独立确认客观疾病进展前，不得改变其给药方案； 10.筛选前2年内接受过任何研究性治疗性疫苗，或筛选前4周内接受过任何其他研究性产品治疗； 11.筛选前4周内接受过重大手术（如需全身麻醉），或未从手术中恢复；或计划在研究期间进行重大手术；仅使用局部麻醉的近期或计划手术患者可参与研究； 12.首次KMV002给药前2年内，除本研究疾病外被诊断其他恶性肿瘤，以下情况除外：皮肤鳞状细胞癌或基底细胞癌、非肌层浸润性膀胱癌，以及经研究者和医学质量控制员一致认为已治愈或首次KMV002给药后1年内复发风险极低的任何恶性肿瘤； 13.病理性长骨骨折、即将发生的病理性长骨骨折（影像学显示皮质侵蚀＞50%）或脊髓压迫； 14.患有骨Paget病； 15.筛选前12个月内，存在需要系统性免疫抑制药物治疗的活动性自身免疫性疾病； 16.曾有显著局部或全身免疫原性事件，或对CpG 1018存在过敏史； 17.存在任何可能影响患者接受或耐受计划治疗、理解知情同意书的严重基础疾病或其他情况；或经研究者判断，参与研究不符合患者最佳利益。

Exclusion criteria：

If the patient meets any of the following exclusion criteria, they are not eligible to participate in this study: 1. Has known brain metastases, malignant pleural effusion or malignant ascites; 2. Has not recovered to <= grade 1 or baseline level of toxicity related to previous anti-tumor treatment (excluding alopecia, vitiligo, grade 2 peripheral neuropathy and radiation-induced tissue fibrosis); 3. Has been prohibited from using any of the following drugs within 28 days before screening or during the study: Systemic corticosteroids (dose not less than equivalent to 5 mg prednisone per day) - Not allowed to use within 1 month before enrollment; Inhalation, nasal or topical corticosteroids are allowed; Abiraterone or other anti-tumor drugs that must be routinely combined with systemic corticosteroids; PC-SPES 5α-reductase inhibitors - If the patient has been continuously using them for at least 28 days before enrollment, they can continue to use them throughout the treatment period, but new use is not allowed during the study period; Ethinylestradiol Radium-223 (Xofigo®) Any other hormone-based drugs or supplements intended for cancer treatment 4. At any time before screening, has received or plans to receive treatment targeting prostate acid phosphatase; 5. Within 4 weeks before the first study medication administration, has received or plans to receive any vaccine (except for vaccines authorized by local health authorities for emergency use, such as COVID-19 vaccine, rabies vaccine, tetanus toxoid vaccine, etc.); 6. Has received external beam radiotherapy within 4 weeks before screening, or is expected to receive radiotherapy during the study period; 7. Has received cytotoxic chemotherapy within 3 months before screening, or has received more than 2 chemotherapy regimens at any time before screening; 8. Has needed to receive opioid analgesics for any reason within 4 weeks before screening; 9. Has started or discontinued bisphosphonate treatment within 24 weeks before screening, and patients on bisphosphonate treatment cannot change their dosage plan until the independent confirmation of objective disease progression; 10. Has received any investigational therapeutic vaccine within 2 years before screening, or has received any other investigational product treatment within 4 weeks before screening; 11. Has undergone major surgery (requiring general anesthesia) within 4 weeks before screening, or has not recovered from the surgery; or plans to undergo major surgery during the study period; Patients with recent or planned surgery using local anesthesia can participate in the study; 12. Within 2 years before the first administration of KMV002, has been diagnosed with other malignant tumors except for the disease under study, except for the following situations: squamous cell carcinoma or basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, and any malignant tumor that the investigator and medical quality control officer unanimously consider has been cured or has a very low risk of recurrence within 1 year after the first administration of KMV002; 13. Pathological long bone fractures, impending pathological long bone fractures (with cortical erosion > 50% on imaging), or spinal cord compression; 14. Has Paget's disease of bone; 15. Has had active autoimmune diseases requiring systemic immunosuppressive drug treatment within 12 months before screening; 16. Has had significant local or systemic immune response events, or has an allergy history to CpG 1018; 17. Has any serious underlying disease or other conditions that may affect the patient's ability to receive or tolerate the planned treatment, understand the informed consent form, or is judged by the investigator to not be in the best interest of the patient.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2029-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-09-01 00:00:00 至 To 2027-03-15 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	10
Group：	Experimental group	Sample size：	10
干预措施：	接受不同剂量的KMV002肿瘤治疗性疫苗诱导免疫。，本试验采用双剂量爬坡策略，从小剂量起始，探索不同组合剂量在mAPMR患者中的安全性和耐受性。在剂量递增方法上，本研究采用加速滴定联合“3+3”的两阶段设计。加速滴定阶段采用单患者队列和快速剂量爬坡，可减少暴露于亚治疗剂量的患者数量，缩短试验周期，适用于预期毒性较低的免疫治疗药物。当加速滴定阶段首次出现DLT或2例患者出现中度毒性时，设计自动转换为标准的“3+3”设计。	干预措施代码：
Intervention：	The immune response was induced by administering different doses of the KMV002 tumor therapeutic vaccine. This trial employed a double-dose ramp-up strategy, starting with a low dose and exploring the safety and tolerability of different combination doses in patients with mAPMR. In terms of the dose escalation method, this study adopted an accelerated titration combined with a two-stage design of "3+3". The accelerated titration stage utilized single-patient cohorts and rapid dose ramp-up, which could reduce the number of patients exposed to subtherapeutic doses, shorten the trial period, and was suitable for immunotherapy drugs with lower expected toxicity. When the first DLT occurred in the accelerated titration stage or two patients experienced moderate toxicity, the design automatically converted to the standard "3+3" design.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三甲
Institution hospital：	The West China Hospital of Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	评估接受不同剂量的KMV002肿瘤治疗性疫苗诱导免疫后的安全性和耐受性，包括不良事件（AE）的发生率、严重程度以及剂量限制性毒性（DLT）	指标类型：	主要指标
Outcome：	Evaluate the safety and tolerability of tumor therapeutic vaccine KMV002 after inducing immunity at different doses, including the incidence and severity of adverse events (AEs) and dose-limiting toxicities (DLTs)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	评估不同剂量的KMV002诱导的免疫激活效应，特别是PAP特异性免疫应答（抗PAP T细胞反应）	指标类型：	次要指标
Outcome：	Assess the immune activation effects induced by different doses of KMV002, particularly PAP-specific immune responses (anti-PAP T cell responses)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	探索KMV002对T细胞增殖、IFN-γ等细胞因子及其他免疫激活标志物的影响	指标类型：	附加指标
Outcome：	Exploring the effects of KMV002 on T cell proliferation, IFN-γ and other cytokines, and other immune activation markers	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	初步观察抗肿瘤活性，包括客观缓解率（ORR）、影像学无进展生存期（rPFS）	指标类型：	附加指标
Outcome：	Preliminary observation of anti-tumor activity, including objective response rate (ORR) and radiographic progression-free survival (rPFS)	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	评估前列腺特异性抗原（PSA）缓解率（PSA水平较基线下降≥50%的比例）	指标类型：	附加指标
Outcome：	Evaluate prostate-specific antigen (PSA) response rate (the proportion of PSA levels decreasing by ≥50% from baseline)	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	80	岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-06-12 17:05:00